Drug Information Update - PerformRx Information Update June...saxagliptin hcl 5 mg-5 mg tablet new strength tx for adhd/narcolepsy adhansia xr methylphenidate hcl 25, 35, 45, 55, 70,

Page 0 of 124

Drug Information Update June 2019

Page 1 www.performrx.com

200 Stevens Drive, Philadelphia, PA 19113 Copyright © PerformRx LLC 2019. All Rights Reserved

TABLE OF CONTENTS

NEWLY AVAILABLE GENERICS ................................................................. 2

NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS ............................... 3

NEW INDICATIONS (EXISTING DRUGS) .................................................... 5

FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS .............................. 8

STUDIES AND RECENT TOPICS ............................................................... 14

RECALLS ................................................................................................ 18

CURRENT DRUG SHORTAGES ................................................................ 60



NEWLY AVAILABLE GENERICS

GENERIC DRUG NAME STRENGTH & DOSAGE

FORM GENERIC

MANUFACTURER BRAND NAME

SILDENAFIL CITRATE 10 MG/ML ORAL

SUSPENSION NOVITIUM PHARMA REVATIO

NAFTIFINE HCL 1% GEL IMPAX, AMNEAL NAFTIN

FULVESTRANT 250 MG/5 ML SYRINGE SANDOZ FASLODEX

SCOPOLAMINE 1 MG/3 DAY PATCH MYLAN TRANSDERM-SCOP

DICYCLOMINE HCL 10 MG/ML AMPULE AKORN

BENTYL



NEW DRUG ENTITIES/COMBINATIONS/STRENGTHS

DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

TOPICAL LOCAL ANESTHETICS

NUVAKAAN LIDOCAINE/PRILOCAINE

/SILICONE 2.5 %-2.5% TOPICAL

KIT

RX CREAM + OTC SILICONE GEL DRESSING

TOPICAL LOCAL ANESTHETICS

LIDOPURE PATCH LIDOCAINE/

KINESIOLOGY TAPE 5 % TOPICAL PATCH

RX PATCH + DEVICE TAPE

TOPICAL ANTI-INFLAMMATORY

STEROIDAL FLUOVIX

FLUOCINONIDE/ SILICONE, ADHESIVE

0.1 % TOPICAL KIT RX CREAM +

OTC SILICONE GEL DRESSINGS

ANTINEOPLASTICS ANTIBODY/ANTIBODY-

DRUG COMPLEXES POLIVY

POLATUZUMAB VEDOTIN-PIIQ

140 MG VIAL NEW ENTITY

OXIDIZING AGENTS DELUO HYPOC ACID/SOD

HYPO/NACL/WATER

0.018 %-0.004 %-0.06 % TOPICAL

SPRAY

REGULATED AS MEDICAL DEVICE

MONOCLONAL ANTIBODY - INTERLEUKIN-5 ANTAGONISTS

NUCALA MEPOLIZUMAB 100 MG/ML SQ SYRINGE, AUTO-

INJECTOR

NEW DOSAGE FORM

CALCITONIN GENE-RELATED PEPTIDE (CGRP)

INHIBITORS EMGALITY SYRINGE

GALCANEZUMAB-GNLM

100 MG/ML SYRINGE

NEW STRENGTH

AGTS TX NEUROMUSC TRANSMISSION DIS, POT-

CHAN BLKR RUZURGI AMIFAMPRIDINE 10 MG TABLET NEW ENTITY

TOPICAL PREPARATIONS, ANTIBACTERIALS

DERMAZENE HYDROCORTISONE/

IODOQUINOL 1 %-1 % CREAM

PACK NEW DOSAGE

FORM

ANTINEOPLASTIC SYSTEMIC ENZYME INHIBITORS

PIQRAY ALPELISIB 50, 150, 200 MG

TABLET NEW ENTITY

GENE THERAPY AGENTS - SMN PROTEIN DEFICIENCY

ZOLGENSMA ONASEMNOGENE

ABEPARVOVEC-XIOI 2X10E13/ML IV KIT NEW ENTITY

TOPICAL ANTI-INFLAMMATORY

STEROIDAL BESER KIT

FLUTICASONE/ EMOLLIENT NO.65

0.05% TOPICAL KIT RX + COSMETIC

ANTHELMINTICS EGATEN TRICLABENDAZOLE 250 MG TABLET NEW ENTITY

NEUROMUSCULAR BLOCKING AGENTS

(COSMETIC) JEUVEAU

PRABOTULINUMTOXINA-XVFS

100 UNIT VIAL NEW ENTITY



DESCRIPTION BRAND NAME GENERIC NAME STRENGTH NOTES

ANTIHYPERGLYCEMIC QTERN DAPAGLIFLOZIN/ SAXAGLIPTIN HCL

5 MG-5 MG TABLET NEW

STRENGTH

TX FOR ADHD/NARCOLEPSY ADHANSIA XR METHYLPHENIDATE

HCL 25, 35, 45, 55, 70, 85

MG CAPSULE NEW

STRENGTH

ANTIDEPRESSANT – POSTPARTUM DEPRESSION

(PPD) ZULRESSO BREXANOLONE

100 MG/20 ML VIAL FOR IV

NEW ENTITY

GLUCOCORTICOIDS KENALOG TRIAMCINOLONE

ACETONIDE 80 MG/ML VIAL FOR

INJECTIOB NEW

STRENGTH

TOPICAL LOCAL ANESTHETIC

PRIZOTRAL LIDOCAINE/PRILOC/

LIDOCAINE HCL 2.5 %-2.5% CREAM KIT

TOPICAL LOCAL ANESTHETIC

ZILACAINE LIDOCAINE/SILICONE 5% PATCH RX + DEVICE



NEW INDICATIONS (EXISTING DRUGS)

FRAGMIN® May 16, 2019 The U.S. Food and Drug Administration today approved Fragmin (dalteparin sodium) injection, for subcutaneous use, to reduce the recurrence of symptomatic venous thromboembolism (VTE) in pediatric patients one month of age and older. VTE can include deep vein thrombosis (blood clot in the deep veins of the leg) and pulmonary embolism (blood clot in the lungs), which can lead to death. Source: U.S. Food and Drug Administration (FDA) GATTEX® May 17, 2019 Takeda Pharmaceuticals, U.S.A., Inc. (“Takeda”), announced today that the U.S. Food and Drug Administration (FDA) approved extending the indication of GATTEX® (teduglutide) for injection to pediatric patients 1 year of age and older with Short Bowel Syndrome (SBS) who need additional nutrition or fluids from intravenous (IV) feeding (parenteral support). Source: Takeda Pharmaceuticals, U.S.A., Inc. KEYTRUDA® May 17, 2019 Merck (NYSE: MRK), known as MSD outside the United States and Canada, today announced that the U.S. Food and Drug Administration (FDA) has approved KEYTRUDA, Merck’s anti-PD-1 therapy, as monotherapy in patients whose tumors express PD-L1 (Combined Positive Score [CPS] ≥1) or in combination with platinum and fluorouracil (FU), a commonly used chemotherapy regimen, for the first-line treatment of patients with metastatic or with unresectable, recurrent head and neck squamous cell carcinoma (HNSCC). The approval is based on results from the pivotal Phase 3 KEYNOTE-048 trial, where KEYTRUDA demonstrated a significant improvement in overall survival (OS) compared with the EXTREME regimen (cetuximab with carboplatin or cisplatin plus FU), a standard treatment, as monotherapy in patients whose tumors expressed PD-L1 (CPS ≥1) (HR=0.78 [95% CI, 0.64-0.96]; p=0.0171) and in combination with chemotherapy in the total study population (HR=0.77 [95% CI, 0.63-0.93]; p=0.0067). With these new indications, KEYTRUDA is the first anti-PD-1 therapy approved in the first-line setting as monotherapy in patients whose tumors express PD-L1 (CPS ≥1) or in combination with chemotherapy regardless of PD-L1 expression for patients with metastatic or with unresectable, recurrent HNSCC and the first anti-PD-1 therapy to demonstrate a statistically significant improvement in OS in these patients. Source: Merck



JAKAFI® May 24, 2019 Incyte Corporation (Nasdaq: INCY)today announced that the U.S. Food and Drug Administration (FDA) has approved Jakafi® (ruxolitinib) for the treatment of steroid-refractory acute GVHD in adult and pediatric patients 12 years and older. Jakafi is the first and only FDA-approved treatment for this indication. Source: Incyte Corporation VRAYLAR® May 28, 2019 Allergan plc (NYSE: AGN) and Gedeon Richter Plc. today announced that the U.S. Food and Drug Administration (FDA) has approved a supplemental New Drug Application (sNDA) for VRAYLAR® (cariprazine) for expanded use to treat depressive episodes associated with bipolar I disorder (bipolar depression) in adults. VRAYLAR is also approved in the U.S. to treat manic or mixed episodes associated with bipolar I disorder in adults. There are nearly 11 million adults in the U.S. living with bipolar disorder, a condition that causes extreme shifts in mood, energy, and activity levels. Source: Allergan plc REVLIMID®

May 30, 2019

Celgene Corporation (NASDAQ: CELG) today announced the U.S. Food and Drug Administration (FDA) approved REVLIMID® (lenalidomide) in combination with a rituximab product (R²) for the treatment of adult patients with previously treated follicular lymphoma (FL) or marginal zone lymphoma (MZL) following Priority Review designation. This is the first FDA-approved combination treatment regimen for patients with these indolent forms of non-Hodgkin’s lymphoma (NHL) that does not include chemotherapy. Source: Celgene Corporation

NUCALA® June 6, 2019 GlaxoSmithKline (LSE/NYSE: GSK) today announced that the US Food and Drug Administration (FDA) has approved two new methods for administering Nucala (mepolizumab), an autoinjector and a pre-filled safety syringe, for patients or caregivers to administer once every four weeks, after a healthcare professional decides it is appropriate. This is the first anti-IL5 biologic to be licensed in the US for at-home administration, and the first respiratory biologic to be approved for administration via an autoinjector.



Source: GlaxoSmithKline EMFLAZA® June 7, 2019 PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the U.S. Food and Drug Administration (FDA) approved the company's supplemental New Drug Application (sNDA) for Emflaza® (deflazacort) to expand its labeling to include patients with Duchenne muscular dystrophy who are between 2- and 5-years-old. Duchenne is a rare childhood genetic disorder that causes progressive irreversible muscle deterioration and weakness. Emflaza was first approved by the FDA in February 2017 for the treatment of Duchenne in patients 5-years and older. Source: PTC Therapeutics, Inc. VENCLEXTA® June 13, 2019 South San Francisco, CA -- May 15, 2019 -- Genentech, a member of the Roche Group (SIX: RO, ROG; OTCQX: RHHBY), today announced that the U.S. Food and Drug Administration (FDA) has approved Venclexta® (venetoclax) in combination with Gazyva® (obinutuzumab) for the treatment of people with previously untreated chronic lymphocytic leukemia (CLL) or small lymphocytic lymphoma (SLL). Source: Genentech



FDA NEWS/BULLETINS/ADVISORIES/SAFETY ALERTS

Heritage Pharmaceuticals Inc. Issues Voluntary Nationwide Recall of Amikacin Sulfate Injection, USP 1gm/4 mL (250mg/mL) and Prochlorperazine Edisylate Injection, USP 10mg/2mL (5mg/mL) as a Result of a Sterility Test Failure [Posted 05/28/2019] ISSUE: Heritage Pharmaceuticals Inc. (“Heritage”) East Brunswick, New Jersey, is initiating a voluntary recall of Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), Lot: VEAC025, Expiry Date: October 2019 and Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), Lot: VPCA172, Expiry Date: April 2020, to the consumer level. These drug products are manufactured by Emcure Pharmaceuticals Ltd. (“Emcure”) and distributed by Heritage. The voluntary recall is being initiated due to microbial growth having been detected in one unreleased sublot of Lot VPCA172 and one unreleased sublot Lot VEAC025, which may indicate a lack of sterility in the other sublots. Non-sterile injectable products that are intended to be sterile may result in a site-specific or systemic infection, which in turn may cause hospitalization, organ damage or death. To date, Heritage has not received adverse event reports related to this event. Amikacin Sulfate Injection is indicated in the short-term treatment of serious infections due to susceptible strains of Gram-negative bacteria, including Pseudomonas species, Escherichia coli, species of indole-positive and indole-negative Proteus, Providencia species, Klebsiella-Enterobacter-Serratia species, and Acinetobacter (Mima-Herellea) species. Amikacin Sulfate Injection was manufactured in a sealed vial with a printed label affixed to the vial. Ten (10) labeled vials were packed into a carton along with a leaflet. Fifty-six (56) cartons were packed into one shipper box. Heritage began shipping Amikacin Sulfate Injection, USP, 1g/4 mL (250mg/mL), NDC # 23155-290-42, Lot: VEAC025 on June 22, 2018, and the entire lot was distributed to wholesalers and distributors in United States between June 2018, and August 2018. Prochlorperazine Edisylate Injection is indicated to control severe nausea and vomiting and for the treatment of schizophrenia. Prochlorperazine has not been shown effective in the management of behavioral complications in patients with mental retardation. Prochlorperazine Edisylate Injection was manufactured in a sealed vial with a printed label affixed to the vial. Five (5) labeled vials were packed into one formed PVC tray. Two (2) PVC trays were packed into a carton along with a leaflet. Twenty (20) cartons were packed into one shipper box. Heritage began shipping Prochlorperazine Edisylate Injection, USP, 10mg/2mL (5mg/mL), NDC # 2315529442, Lot: VPCA172, on October 31, 2018, which was distributed to wholesalers and distributors in United States between October 2018, and November 2018. Qualanex is notifying Heritage consignees by recall notification and arranging for return of the recalled product. Consumers should contact their doctor for further guidance and potential change of treatment before they stop taking this drug product. Pharmacies and healthcare facilities that have the products subject



to this recall should immediately stop dispensing this drug product and consumers should immediately stop using any product within these specific lots. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers with questions regarding this recall should contact Qualanex at 1-800-505-9291 Monday – Friday, 8:00 am – 5:00 pm, EST and or [email protected]. Any adverse reactions or quality problems associated with the use of this product may be reported to ProPharma at 1-866-901-3784 at any time, and any such problems may also be reported to FDA's MedWatch Adverse Event Reporting program either by phone, online, by regular mail or by fax. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Complete and submit the report Online. Regular Mail or Fax: Download form or call 1- 800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Source: U.S. Food and Drug Administration (FDA)

FDA highlights concerns with using dietary ingredient glutathione to compound sterile injectables

[Posted 06/07/2019]

Introduction FDA warned compounders on February 1, 2019, not to use glutathione L-reduced powder (L-glutathione) distributed by Letco Medical located in Decatur, Alabama, to compound sterile injectable drugs. FDA received a report concerning seven patients who received an injectable drug compounded with L-glutathione and experienced adverse events due to potentially high levels of endotoxins, a substance that may cause unintended health consequences ranging from fever to death. Exposure to inappropriate levels of endotoxin in a drug intended for injection raises safety concerns. As part of the investigation into the adverse events, FDA collected and analyzed samples of the L-glutathione powder. The following are the details on the adverse events the agency has received to date and the findings from FDA’s investigation. Adverse Events FDA received an adverse event report on January 14, 2019, regarding seven patients in an outpatient clinic who received intravenous injections containing L-glutathione 200mg/mL compounded by a pharmacy using L-glutathione repackaged by Letco (lot number: 1810150050, expiration date: 6/17/2020). According to the report, each patient was administered 7mL (1,400mg) of L-glutathione by injection on January 9, 2019. Within minutes of the infusion, the patients reportedly experienced symptoms of varying degrees, including nausea, vomiting, lightheadedness, chills, body aches and



sneezing. One of the patients experienced low blood pressure and difficulty breathing and was subsequently transferred to a hospital. FDA received another adverse event report on February 4, 2019, associated with an intravenous injection of a drug containing L-glutathione 200mg/mL compounded by a different pharmacy that also used L-glutathione repackaged by Letco (lot number: 1808030045, expiration date: 6/17/2020). According to the report, the patient received an infusion of 12mL (2,400mg) of L-glutathione on October 17, 2018, and experienced sudden chills, fever and shaking, and was subsequently admitted to the hospital for a possible bloodstream infection. FDA’s Investigation The L-glutathione in question was sourced from a foreign manufacturer and repackaged by Letco, an FDA registered repackager. Letco’s L-glutathione label included the statements: “Caution: Dietary Supplement” and “For Manufacturing, Processing, Repackaging and Pharmaceutical Compounding,” and the NDC number, 62991-2171-04 (see Figure 1). Further, Letco’s certificate of analysis (COA) that accompanied the L-glutathione was a translated copy of the manufacturer’s COA. Figure 1

FDA contacted the L-glutathione manufacturer, which confirmed that its L-glutathione is only marketed in the U.S. for use in dietary supplements, and that the ingredient is not intended for use in sterile drugs. The manufacturer’s original invoice for the L-glutathione contained a statement that the product was intended for use as a dietary supplement or dietary ingredient only, and that it was not for pharmaceutical use. However, the manufacturer’s COA that Letco received, did not contain a similar statement. Upon FDA’s recommendation, the manufacturer agreed to amend the L-glutathione label and COA to include clear statements regarding the intended use of this ingredient. The manufacturer also notified its U.S. customers warning against the use of its L-glutathione in sterile drugs. FDA Analysis Accompanying the initial adverse event reports were endotoxin test results from a third-party laboratory, which FDA found concerning. FDA then collected L-glutathione powder samples from Letco and from the pharmacy that compounded the drug associated with the seven adverse events. All samples tested by an FDA laboratory were found to contain excessive bacterial endotoxin with some results as high as five times the appropriate limit, which the agency calculated based on the L-glutathione dose received by the patients. Endotoxin limits should be calculated using the maximum drug dose intended for intravenous (IV) administration. Symptoms associated with exposure to inappropriate endotoxin levels may include fever, chills, myalgia (muscle pain), headache, nausea, vomiting, hypotension (low blood pressure), shock and death.



Conclusion These adverse events were consistent with reactions patients experience with excessive levels of endotoxin, and FDA’s testing confirmed higher levels of endotoxin than is appropriate based on the dose of L-glutathione received intravenously. The L-glutathione powder the pharmacies received was labeled with “Caution: Dietary Supplement” and should not have been used to compound sterile injectable drugs. Ingredients not intended for use in compounding sterile injectable drugs can be harmful when administered to patients because they may contain impurities and contaminants, including endotoxins. It is critical that compounders understand that quality should be built into the drug production, and that testing alone should not be relied on to ensure drug quality. Therefore, compounders should ensure that all ingredients they use to produce sterile injectable drugs are manufactured under conditions and specifications appropriate for the intended route of administration. FDA also urges manufacturers and repackagers to clearly label ingredients intended for use in dietary supplements. Additionally, repackagers should ask the manufacturer about the intended use of the ingredient. Clarifying information on ingredient labels and in the COA could help prevent compounders from using ingredients not appropriate for sterile injectable drugs. FDA encourages consumers, patients and health care professionals to report any adverse events or quality problems experienced with the use of compounded drug products to FDA’s MedWatch Adverse Event Reporting program: Complete and submit the report online at www.fda.gov/medwatch/report.htm; or Download and complete the form, then submit it via fax at 1-800-FDA-0178. Source: U.S. Food and Drug Administration (FDA) Teva Pharmaceuticals USA, Inc. Expands Voluntary Nationwide Recall of Losartan Potassium to 50 mg and 100 mg Tablets USP, Sold Exclusively to Golden State Medical Supply, Inc. [Posted 06/11/2019] Teva Pharmaceuticals USA, Inc. has expanded its voluntary consumer-level recall originally initiated on April 25, 2019 in the United States of losartan potassium tablets. This expanded recall includes six (6) lots of bulk losartan potassium USP Tablets (two lots of 50 mg strength and four lots of 100 mg strength) due to the detection of an impurity – N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) – that is above the US Food & Drug Administration’s interim acceptable exposure limit of 9.82 ppm. The source of the NMBA impurity was detected in one lot of active pharmaceutical ingredient (API), manufactured by Hetero Labs Limited, which was used in the manufacturing of the six (6) bulk lots of these drug products. Based on the available information, there is a potential risk of developing cancer in a few patients following long-term use of products containing high levels of NMBA. For more information on the previous recall initiated on April 25, 2019, go to https://www.tevausa.com/news-and-media/press-releases/teva-pharmaceuticals-usa-inc.-issues-voluntary-nationwide-recall-of-losartan-potassium-25-mg-and-10/. Losartan potassium is indicated for the treatment of hypertension, hypertensive patients with left ventricular hypertrophy, and nephropathy in Type 2 diabetic patients. The bulk lots were sold exclusively



to Golden State Medical Supply, Inc. of Camarillo, California. Golden State Medical Supply, Inc. packaged these bulk products under its own label and distributed retail bottles of 30, 90 and 1000 tablets to their customers. The affected losartan potassium tablets being recalled are described as: Losartan potassium tablets, USP 50 mg, are green, film-coated, oval-shaped biconvex tablets with “LK 50” on one side and ">" on the other side. Losartan potassium tablets, USP 100 mg, are dark green, film-coated, oval-shaped biconvex tablets with “LK100” on one side and ">" on the other side. Teva promptly notified Golden State Medical Supply, Inc. of the presence of the impurity in Hetero’s API and Teva will recall six (6) lots of bulk losartan potassium tablets sold to that company. The tablets, which have been packaged and sold by Golden State Medical Supply, Inc., will be sub-recalled from their customers and patients. Distributors and retailers that have product being recalled should immediately stop distribution, quarantine all remaining product in their control, and return the recalled product per the instructions given to them by Golden State Medical Supply, Inc. Patients taking losartan potassium tablets are advised to continue taking their medication and contact their pharmacist, physician, or medical provider for advice regarding an alternative treatment. The immediate risk of harm to a patient’s health is likely to be higher if the medicine is stopped abruptly without any alternative treatment. For full drug product information, please refer to the full prescribing information for losartan potassium tablets USP. Customers and patients with medical-related questions, who wish to report an adverse event, or quality issues about the Teva products being recalled under the Golden State Medical Supply label should contact Teva Medical Information by phone at: 888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday, 9:00AM-5:00PM Eastern Time with voicemail available 24 hours/day, 7 days/week or by email at [email protected]. Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax. Regular Mail or Fax: Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178 This recall is being conducted with the knowledge of the U.S. Food and Drug Administration. Lots Under Voluntary Recall: the finished product lots that are included in this voluntary recall and listed below were sold by Teva in bulk containers. The bulk tablet lots were repackaged into seven (7) finished product lots for further distribution by Golden State Medical Supply under its product label.

GSMS FG NDCs GSMS FG NDC Description

GSMS FG Product Lots GSMS FG Expiration Dates

60429-317-10 LOSARTAN POTASSIUM 50 mg TABLETS, USP 1000 tablets/bottle

GS017387 01/2020

60429-317-90

LOSARTAN POTASSIUM

50 mg TABLETS 90

GS017651

01/2020



tablets/bottle

60429-317-30

LOSARTAN POTASSIUM

50 mg TABLETS 30 tablets/bottle

GS017479

01/2020

60429-318-90

LOSARTAN POTASSIUM


GS017042

01/2020

60429-318-90

LOSARTAN POTASSIUM


GS017043

01/2020

60429-318-90

LOSARTAN POTASSIUM 100 mg TABLETS, USP

90 tablets/bottle

GS017044

01/2020

60429-318-90

LOSARTAN POTASSIUM 100 mg TABLETS, USP

90 tablets/bottle

GS017541

01/2020

Note – “GSMS FG” refers to Golden State Medical Supply Finished Goods. Patients wishing to return product may contact Teva’s product recall processor to obtain instructions and a return kit for returning their medication: Contact Inmar at 877-789-2065 (Hours of operation: 9 am to 5 pm Eastern Time, Monday – Friday) or email Inmar at: [email protected]. Inmar will provide the materials needed to return their medication and instructions for reimbursement. Customers of Golden State Medical Supply, Inc. may contact them at: (800) 284-8633, ext. 215 Fax: (805) 437-7582 Email: [email protected] For Original Recall go to https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/teva-pharmaceuticals-usa-inc-issues-voluntary-nationwide-recall-losartan-potassium-25-mg-and-100-mg. Source: U.S. Food and Drug Administration (FDA)



STUDIES AND RECENT TOPICS

Study Calculates Incidence of Opportunistic Infections During Ibrutinib Therapy May 20, 2019 A single-institution, retrospective cohort study reported the incidence of opportunistic infections among patients with hematological malignancies who received ibrutinib and identified potential patient risk factors. The study findings were published online May 13, 2019, in Leukemia. Source: cancertherapyadvisor.com SSc-PAH Risk Category Improves With Ambrisentan and Tadalafil Combo Therapy May 21, 2019 DALLAS — Combination treatment with ambrisentan and tadalafil is associated with a reduced mortality risk profile in patients with scleroderma-associated pulmonary arterial hypertension (SSc-PAH), according to study findings presented at the American Thoracic Society International Conference held May 17-22 in Dallas, Texas. Source: pulmonologyadvisor.com Array BioPharma's colorectal cancer combo treatment meets main goals May 21, 2019 Array BioPharma Inc’s cocktail of three therapies helped patients with a type of colorectal cancer live longer than those on standard treatment, according to interim results of a late-stage study on Tuesday. The combination therapy, comprising Array’s Braftovi and Mektovi and Eli Lilly and Co’s Erbitux, helped half the patients enrolled in the study survive nine months. Source: reuters.com Aspirin, Anti-Clotting Meds Safe After Bleeding Stroke: Study May 22, 2019 Taking aspirin or anti-clotting medicines like Plavix won't boost the risk of another stroke if you've already survived a bleeding stroke, a new study suggests. In fact, they might even help guard against a second brain bleed, the researchers noted. Source: healthday.com Alemtuzumab is Effective to Treat RRMS in Patients of African Descent May 28, 2019 SEATTLE — Alemtuzumab is efficacious and safe in the long term to treat high-risk patients with multiple sclerosis (MS) who are of African descent, according to research presented at the 2019 Consortium of Multiple Sclerosis Centers Annual Meeting, held May 28 to June 1, 2019, in Seattle, Washington. Source: neurologyadvisor.com



Medication Adherence, QOL Better in Heart Failure Patients Who Regularly Visited Pharmacist May 28, 2019 Elderly patients with heart failure adhered better to their recommended medications when they saw a pharmacist once a week, according to late breaking results from the PHARM-CHF randomized controlled trial presented this week at Heart Failure 2019, a scientific congress of the European Society of Cardiology (ESC). Source: pharmacytimes.com New Opioid-Free Pain Reliever Under Priority Review May 29, 2019 Officials with the FDA have given Priority Review designation to an opioid-free pain management treatment from Galt Pharmaceuticals. According to the company, its Supplemental Abbreviated New Drug Application for the orphenadrine citrate, aspirin and caffeine combination (Orphengesic Forte), a muscle relaxant pain reliever, was given an August 2019 goal for approval. Source: pharmacytimes.com Severe respiratory failure strikes healthy teens on trimethoprim-sulfamethoxazole May 29, 2019 Trimethoprim-sulfamethoxazole (TMP-SMX) was linked to severe acute respiratory distress syndrome (ARDS) in five previously healthy teens, two of whom died. TMP-SMX, a frequently prescribed antibiotic, has been associated with “idiosyncratic adverse drug reactions, including cutaneous reactions and hypersensitivity syndromes,” but pulmonary complications are rare, especially in children, wrote Jenna O. Miller, MD, of the University of Missouri–Kansas City and colleagues. Source: mdedge.com Oral Minoxidil Possibly Effective for Male Androgenetic Alopecia May 30, 2019 Once-daily 5-mg oral minoxidil may be an effective and safe treatment option for male androgenetic alopecia, according to study results published in the Journal of the American Academy of Dermatology. Source: dermatologyadvisor.com Olorinab for Abdominal Pain Associated with Crohn's Disease May 30, 2019 In a recent, open-label study, investigators found use of olorinab could result in an improvement in average abdominal pain score (AAPS) without psychotropic effects in subjects with Crohn’s disease (CD) experiencing abdominal pain.



Source: mdmag.com

Many Heart Failure Patients Might Safely Reduce Use of Diuretics May 31, 2019 Heart failure is a common ailment afflicting older Americans, and many take drugs called diuretics to rid the body of excess fluid buildup that can impede breathing. Now, a team of Brazilian researchers say that, in some cases, it's safe for patients with stable heart failure to stop taking diuretic drugs. Source: consumer.healthday.com Biologic medication for arthritis and psoriasis have flooded the market — and been linked to 34,000 deaths June 2, 2019 With her kidneys and liver failing and a 106-degree temperature that had smoldered for days, Helen Tschannen was being kept alive on a ventilator. Doctors were not certain what was happening, but the family knew this: Tschannen, 77, did not want to be kept alive by machines. After 21 days in an Illinois hospital, they gathered at her bedside and wrestled with whether they were doing the right thing. Source: jsonline.com US aims to help more cancer patients try experimental drugs June 3, 2019 CHICAGO (AP) — Sally Atwater’s doctor spent two months on calls, messages and paperwork to get her an experimental drug he thinks can fight the lung cancer that has spread to her brain and spine. Nancy Goodman begged eight companies to let her young son try experimental medicines for a brain tumor that ultimately killed him, and “only three of the companies even gave me a reason why they declined,” she said. Source: apnews.com Heartburn Drugs Again Tied to Fatal Risks June 6, 2019 People who use common heartburn drugs for months to years may face heightened risks of dying from heart disease, kidney failure or stomach cancer, a new study suggests. The study included more than 200,000 U.S. veterans. It's the latest to raise concerns over drugs called proton pump inhibitors (PPIs). They include prescription and over-the-counter drugs like Prilosec (omeprazole), Prevacid (lansoprazole) and Nexium (esomeprazole). And they rank among the top-selling medications in the United States. Source: consumer.healthday.com



COPD Hospitalization Risk Linked to Opioid/Benzodiazepine Use June 11, 2019 Opioid and benzodiazepine use was associated with more adverse respiratory events in older adults with chronic obstructive pulmonary disease (COPD), according to a study published in Annals of the American Thoracic Society. Source: pulmonologyadvisor.com



RECALLS

Product Type

Product Description

Classification Code Info Reason For Recall

Recalling Firm

Drugs Promacta (eltrombopag)

12.5 mg for Oral Suspension, Rx

Only Manufactured by:

Halo Pharmaceuticals, Inc. Whippany,

New Jersey 07981 Distributed by:

Novartis Pharmaceuticals Corporation East

Hanover, NJ 07936 Product of

Ireland, NDC 0078-0972-61.

Class I Lot #: 8H57901589, Exp. 09/2020; 9H57900189 and 9H57900289, Exp.

12/2020.

Cross Contamination

with Other Products:

product is being recalled due to possible cross-contamination

with peanut flour.

Novartis Pharmaceuticals

Corp.

Drugs Articaine DENTAL, Articane

hydrochloride 4% and epinephrine 1:100,000, 50

cartridges. 1.7 mL each, Rx only,

Manufactured for: DENTSPLY

Pharmaceutical, by Novocol

Pharmaceutical of Canada, Inc. York,

PA 17404, NDC 66312-601-16

Reorder #: 51116

Class I Lot # D02599A, exp. Sept 2020, D02608B,

exp. October 2020

Labeling: Not Elsewhere

Classified. This recall has been initiated due to mislabeling. The printed carton

used in manufacturing both batches

contained text for both 2% Xylocaine

DENTAL and Articadent DENTAL. Xylocaine

DENTAL is a trade name for

Lidocaine HCL 2% and Epinephrine

1: 100,000 formulation,

while Articadent DENTAL is a trade

Septodont Inc.



Product Type

Product Description


Recalling Firm

name for Articaine HCI 4% and Epinephrine 1 :100,000. The

cartridges contained within

the printed carton are

labeled appropriately as

Articadent DENTAL.

Drugs Losartan Potassium Tablets,

USP 50 mg 1000 film coated tablets

Rx Only Manufactured by:

Vivimed Life Sciences Private Limited, Plot No. 101, 102, 107 &

108 SIDCO Pharmaceutical

Complex, Alathur, Kanchipuram -

603 110, Tamilnadu, India.

Manufactured for: Heritage

Pharmaceuticals Inc., East

Brunswick, NJ 08816. 1-866-901-DRUG (3784) NDC

23155-645-10

Class I Lot CLO17007A Lot CLO17008A Lot CLO17009A ; Exp

11/2019

CGMP Deviations: FDA lab confirmed presence of an

impurity, N-Methylnitrosobutyric acid (NMBA)

in the finished product above

the interim acceptable daily intake level at

the manufacturer

Heritage Pharmaceuticals

, Inc.

Drugs Losartan Potassium Tablets

USP 100 mg 90 film coated tablets Manufactured by:


Class I Lot CLO17012A exp 11/2019 Lot CLO17013A exp 11/2019 Lot CLO18002A exp

01/2020 Lot CLO18020A exp






, Inc.



Product Type

Product Description


Recalling Firm






Brunswick, NJ 08816. 1-866-901-

DRUG (3784) NDC 23155-646-

09


04/2020


the manufacturer

Drugs Losartan Potassium Tablets USP 50 mg 90 film

coated tablets Manufactured by:







Brunswick, NJ 08816. 1-866-901-

DRUG (3784) NDC 23155-645-

09

Class II Lot CLO17009B exp 11/2019 Lot

CLO17010A exp 11/2019 Lot

CLO18023A exp 04/2020





the manufacturer


, Inc.

Drugs Losartan Potassium Tablets USP 100 mg 1000

film coated tablets Rx only

Manufactured by:

Class II CLO17014A exp 12/2019 CLO17015A

exp 01/2020 CLO17016A exp

01/2020 CLO17017A exp 01/2020


impurity, N-Methylnitrosobut


, Inc.



Product Type

Product Description


Recalling Firm







Brunswick, NJ 08816. 1-866-901-

DRUG (3784) NDC 23155-646-

10

CLO18001A exp 01/2020 CLO18002B

exp 01/2020

yric acid (NMBA) in the finished product above


the manufacturer

Drugs Losartan Potassium Tablets USP 25 mg 90 film coated tablets Rx

Only Manufactured by:







Brunswick, NJ 08816. 1-866-901-

DRUG (3784) NDC 23155-644-

09

Class II Lot CLO17006A exp 11/2019





the manufacturer


, Inc.



Product Type

Product Description


Recalling Firm

Drugs Amitiza (lubiprostone)

capsules, 8 mcg, 60-count bottle,

Rx only, Manufactured by: Sucampo Pharma

Americas, LLC, NDC 64764-080-

60

Class II Lot #: 3229691-61, Exp 01/2022

Labeling: Label mix-up. Amitiza 8 mcg capsules are

being recalled because 24 mcg capsules were found in an 8

mcg trade 60 ct. bottle. Amitiza

24 mcg capsules are being

recalled because a sealed 60 ct.

bottle contained only 8 mcg

capsules, this incident is being considered as a labeling mix-up

issue.

MALLINCKRODT PHARMACEUTIC

ALS

Drugs Amitiza (lubiprostone)

capsules, 24 mcg, 60-count bottle,

Rx only, Manufactured by: Sucampo Pharma

Americas, LLC, NDC 64764-240-

60

Class II Lot #: 3200626-61, Exp 02/2022

Labeling: Label mix-up. Amitiza 8 mcg capsules are

being recalled because 24 mcg capsules were found in an 8

mcg trade 60 ct. bottle. Amitiza

24 mcg capsules are being

recalled because a sealed 60 ct.

bottle contained only 8 mcg

capsules, this incident is being considered as a labeling mix-up

issue.

MALLINCKRODT PHARMACEUTIC

ALS


USP 25 mg 30 count bottle NDC 60429-316-30 Rx

Class II GS017981 exp 02/2020, GS016958 exp 02/2020, GS017341 exp 02/2020


impurity, N-

Golden State Medical Supply

Inc.



Product Type

Product Description


Recalling Firm

only GSMS Incorporated

Methylnitrosobutyric acid (NMBA)



the manufacturer




Class II GS015172 exp 06/2019 GS017634 02/2020,

GS017653 exp 02/2020, GS017980 exp 02/2020, GS017276 exp 02/2020,

GS017045 exp 02/2020,GS016726 exp

02/2020,





the manufacturer


Inc.

Drugs Losartan Potassium Tablets USP 25 mg 1000 count bottle NDC 60429-316-10 Rx


Class II GS015204 exp 06/ 2019, GS018318 exp 02/2020, GS014817 exp 06/2019, GS017342 exp 02/2020, GS017808 exp 02/2020





the manufacturer


Inc.




Class II GS014045,exp 06/2019, GS014305 exp 06/2019, GS014044 exp 0/2019,

GS016535 exp 01/2020, GS016524 exp 01/2020, GS017384 exp 02/2020, GS017385 exp 01/2020, GS017539 exp 01/2020, GS017540 exp 01/2020, GS017543 exp 01/2020, GS017542 exp 01/2020




the interim acceptable daily


Inc.



Product Type

Product Description


Recalling Firm

GS017984 exp 02/2020, GS017985 exp 02/2020, GS017986 exp 02/2020, GS018263 exp 02/2020, GS018264 exp 02/2020, GS018265 exp 02/2020

intake level at the manufacturer

Drugs Losartan Potassium Tablets USP 100 mg 1000 count bottle NDC 60429-318-10 Rx


Class II GS014054 exp 06/2019, GS016338 exp 12/2019, GS016341 exp 01/2020, GS016342 exp 01/2020, GS016343 exp 01/2020, GS016344 exp 01/2020, GS016345 exp 01/2020, GS016539 exp 01/2020, GS016969 exp 01/2020, GS016973 exp 01/2020, GS017337 exp 01/2020, GS018524 exp 02/2020





the manufacturer


Inc.

Drugs ANTIBACTERIAL Foaming Hand

Wash With Moisturizers

labeled as Antibacterial

Foaming Soap, ACTIVE:P.C.M.X,

packaged in a) 18 oz bottles, 12/18

oz bottles per case, 5063-432-02; b) 1 gallon

bottles, 4/1 gallon bottles per case, 5063-420-03; c) Options Systems

Antibacterial Foaming Hand Wash with .3%

PCMX, packaged in 1000mL pouches,

6/1000ML pouches per case, 5063-OS1000; d)

Class II Batch #: 6657, 6666, 6671, 6679, 6687, 6695, 6702, 6718, 6730, 6744, 6754, 6760, 6772, 6773, 6784, 6793, 6804, 6812, 6819, 6838, 6846, 6856, 6862, 6877, 6890, 6896, 6902, 6910, 6919, 6938, 6944, 6953, 6971, 6985, 6990, 6998, 7005, 7012, 7018, 7028, 7033, 7039, 7043, 7053, 7060, 7068, 7080, 7092, 7101, 7110, 7116, 7126, 7143, 7153, 7161, 7167, 7175, 7188, 7204, 7208, 7213, 7221, 7232, 7242, 7248, 7267, 7275, 7284, 7287, 7295, 7308, 7314, 7324, 7329, 7336, 7348, 7357, 7363, 7372, 7382, 7389, 7397,

7403, and 7411

CGMP Deviations: hand

sanitizers and soaps were not produced under

current good manufacturing

practices.

Inopak Ltd



Product Type

Product Description


Recalling Firm

INOFOAM Antibacterial

Foaming Hand Wash with .3%

PCMX, packaged in 1000mL

pouches, 6-1000ml pouches per case, 5063-FL1000, Inopak

LTD., 24 Executive Parkway,

Ringwood, NJ 07456.

Drugs AQUACIL instant foaming hand

sanitizer, alcohol free formula, benzalkonium chloride 0.1%

(w/w), packaged in a) 18 FL OZ (532

mL) bottles, 12/18OZ bottles per case, Product Code BIO-5075-432-02; b) 1000

ML pouches, 6/1000 ML

pouches per case, Product Code

BIO575-OS1000, Biocentris

Pharmaceuticals (Division of

Inopak).

Class II Batch #: 6736, 6826 CGMP Deviations: hand



practices.

Inopak Ltd

Drugs Instant Waterless Hand Sanitizer, Ethyl Alcohol,

62%, packaged as a) DermaGel

Instant Waterless Hand Sanitizing

Gel with Moisturizers, with

Class II Batch #: 7069, 6648, 6649, 6652, 6654, 6667, 6669, 6675, 6677, 6684, 6686, 6692, 6694, 6703, 6704, 6710, 6717, 6719, 6726, 6727, 6731, 6733, 6739, 6743, 6748, 6751, 6752, 6759, 6763, 6767, 6769, 6771, 6775, 6776,




practices.

Inopak Ltd



Product Type

Product Description


Recalling Firm

Aloe Vera & Vitamin E,

packaged in a) 1000 ml Disc

Pump pouches (NDC 58575-340), 8 x 1000 ml Disc

Pump pouches per case, Product

Code 5025-L1000; b) 2 fl. oz. bottles,

80/2 oz bottles per case, 5025-480-02; c) 18 fl. oz. bottles (NDC

58575-340), 16/18 oz bottles per

case, 5025-430-02; d) 8 FL OZ. bottle, 24/8 oz bottle per case,

5025-440-03; e) 4 fl. oz. bottles, 24 x

4oz. Bottles per case, 5025-450-

03; f) 800 ml pouches, 12 x 800 ml Universal Valve pouches per case, 5025-404-NB; g) 1 Gallon bottles, 4/1 gallon bottles per case, 5025-4202-02; Inopak LTD.,

Ringwood, NJ 07456. SaniTyze Hand Sanitizer with Aloe Vera,

Vitamin E & Keratin, packaged as h) 8 fl oz (237 ml) bottles, 24/ 8

Oz. bottles per case;

Manufactured for Crosstex

6780, 6782, 6787, 6788, 6801, 6805, 6808, 6811, 6814, 6815, 6821, 6824, 6825, 6830, 6831, 6836, 6843, 6845, 6852, 6859, 6860, 6874, 6878, 6880, 6881, 6884, 6889, 6897, 6900, 6903, 6905, 6912, 6920, 6922, 6926, 6928, 6931, 6940, 6945, 6948, 6951, 6954, 6962, 6967, 6969, 6972, 6975, 6980, 6986, 6989, 6995, 7002, 7015, 7023, 7029, 7030, 7035, 7044, 7047, 7048, 7051, 7059, 7062, 7066, 7072, 7073, 7079, 7081, 7084, 7085, 7088, 7090, 7095, 7096, 7099, 7102, 7105, 7112, 7113, 7115, 7124, 7125, and 7128.



Product Type

Product Description


Recalling Firm

International, Inc., 10 Rarick Road, Hauppague, NY

11788-4209.

Drugs INODERM Antiseptic Hand Soap (E-2), .6%

(incorrectly labeled on bags as

75%) PCMX, 800ml/27fl.oz.pou

ches (NDC 058575-110), 12 x

800 Bag-N-Box pouches per case

(NDC 058575-110-80), 5014-404-NB;

INOPAK, 24 Executive PKWY,

Ringwood, NJ 07456.

Class II Batch #: 7074 CGMP Deviations: hand



practices.

Inopak Ltd

Drugs INOFOAM Foaming E-2 Food

Handling Wash with .6% PCMX, 1000mL pouch

(NDC 058575-110-11), 6/1000 ML

pouches per case (NDC 058575-110-80), 5064-FL1000,

Inopak, LTD.

Class II Batch #: 7304, 7180, 6707, 7065




practices.

Inopak Ltd

Drugs Antibacterial Hand Soap, Healthcare

2000, labeled as a) DERMA System CARE SaniClenz

Antimicrobial Skin Cleanser

(Chlorhexidine Gluconate), 4 x (1 gallon containers),

Reorder/REF #JSCG;

Manufactured for

Class II Batch #: 6802, 6803, 6909, 6655




practices.

Inopak Ltd



Product Type

Product Description


Recalling Firm

Crosstex International, Inc.;

b) MEDI-WASH CHG Anti-

Microbial Hand Wash with

Chlorhexidine Gluconate;

1000ML pouches, 8/1000ML

pouches per case, Walter G. Legge

Co Inc, 444 Central AVE, Peekskill, NY

10566

Drugs Mild Health Care Antibacterial Hand

Soap, .6% P.C.M.X.,

packaged in a) 1000 ml Disc

Pump pouches, 8 x 1000 ml Disc

Pump pouches per case, 5013-L1000, b) 2000 ml. Disc

Pump pouches, 4 x 2000 ml Disc

Pump pouches per case, 5013-

XL2000, c) 800 ml Universal Valve

pouches, 12 x 800 ml Universal Valve pouches per case,

5013-404, d) 1 gallon bottles, 4/1 gallon bottles per case, 5013-420-

02, INOPAK, LTD., 24 Executive

Parkway, Ringwood, NJ

07456.

Class II Batch #: 6656, 6959, 7008




practices.

Inopak Ltd



Product Type

Product Description


Recalling Firm

Drugs Sani-Guard-SF Waterless Foam Hand Sanitizer,

Ethyl Alcohol 70%, packaged in a)

6/1000 ml pouches per case, 5068-FL1000, b)

1000 ml cartridge pouch, 6/1000 ml

.8ml Option Cartridge pouches

per case, 5068-OS1000, Inopak

LTD

Class II Batch #: 6668, 6721 CGMP Deviations: hand



practices.

Inopak Ltd

Drugs Antibacterial Hand Soap, .3% P.C.M.X,

labeled as STYLE Antibacterial Hand

Soap with moisturizers, a)

1000 ml pouches, 10/1000 ML. Large Valve pouches per

case, 5031-404-LN, b) 1000 ml

pouches, 8/1000 ML. Disc Pumps

pouches per case, 5031-L1000, c)

800 ML Universal Valve pouches,

12/800 ML Universal Valve

pouches per case, 5031-404, d) 800

ml pouches, 12/800 ML

Presspak pouches per case, "B",

5031-403-1B, e) 800 ml pouches, 12 x 800ML. KC

Valve pouches per case, 5031-404-

Class II Batch #: 6660, 6664, 6676, 6682, 6685, 6698

,6701, 6725, 6732, 6742, 6744, 6746, 6756, 6762, 6770, 6777, 6792, 6798, 6807, 6813, 6816, 6820, 6829, 6839, 6868, 6872, 6875, 6891, 6892, 6904, 6906, 6914, 6916, 6923, 6932, 6939, 6952, 6958, 6963, 6970, 6978, 6982, 6987, 6993, 6997, 7004, 7006, 7024, 7038, 7049, 7054, 7056, 7058, 7078, 7087, 7098, 7104, 7108, 7111, 7129, 7132, 7134, 7138, 7145, 7152, 7157, 7160, 7164, 7170, 7177, 7184, 7190, 7192, 7203, 7207, 7220, 7224, 7231, 7235, 7237, 7243, 7247, 7252, 7258, 7260, 7269, 7281, 7285, 7291, 7296, 7301, 7306, 7311, 7312, 7319, 7322, 7326, 7335, 7338, 7340, 7347, 7351, 7353, 7368, 7377, 7384,

7387, 7394 and 7399




practices.

Inopak Ltd



Product Type

Product Description


Recalling Firm

KC, f) 800 ml pouches, 12/800

ML Universal Valve pouches per case, 5031-404, g) 800 ml pouches,

12/800 ML Presspak pouches

per case, "B", 5031-403-1B, h) 500 ml pouches,

6/500 ML. KC Valve pouches per

case, 5031-404-500-6, i) 500 ml

pouches, 18/500 ML. KC Valve

pouches per case, 5031-404-500, j) 500 ml pouches,

6/500 ML. KC Valve pouches per

case, 5031-404-500-6, k) 8 oz.

bottles, 24/8 OZ. bottles with

pumps per case, 5031-440-03, l) 18 oz. bottles, 16 x 18

OZ. Bottles with Pumps per case, 5031-430-02, m) 1000 ml pouches,

10/1000 ML. Large Valve pouches per

case, 5031-404-LN, n) 1000 ml

pouches, 8/1000ML. Disc Pumps pouches per case, 5031-L1000; Choice

Antibacterial Hand Soap, packaged as o) 800 ml/27fl.oz. pouches, 12/800



Product Type

Product Description


Recalling Firm

ml Universal Valve pouches per case, 5031-404UV-CH, Manufactured by

Inopak LTD., Ringwood, NJ.

Drugs Unison Hand Care Products, WHITE PEARLIZED Anti-Bacterial Hand Cleaner with

Triclosan, #4302, with exclusive

Bajan fragrance, packaged in 800

ML (27 FL OZ) pouch containers,

12-800 ml containers/12-27 FL. OZ. container pouches per case, National Chemical Laboratories, Inc.,

401 North 10th Street,

Philadelphia, PA 19123.

Class II Batch # 6827 CGMP Deviations: hand



practices.

Inopak Ltd

Drugs Bevacizumab 2.5 mg/0.1 mL,

packaged in a Prefilled Syringe, Rx only, AVELLA

SPECIALTY PHARMACY 24416 N. 19TH AVENUE

PHOENIX, AZ 85085, NDC

42852-001-27

Class II Lot #: 138-20191202@64, Exp

05/13/19

Lack of assurance of sterility

Avella of Deer Valley, Inc. Store

38

Drugs Cefdinir for Oral Suspension USP,

250mg/5mL, Powder for oral

suspension, 60 mL bottle, Rx only,

Manufactured for:

Class II Lot # F802335, exp. date November 2020

Complaint received of metal piece identified in the product bottle prior to

the reconstitution.

Lupin Pharmaceuticals

Inc.



Product Type

Product Description


Recalling Firm

Lupin Pharmaceuticals, Inc., Baltimore,

Maryland 20201, Manufactured by:

Lupin Limited, Mandideep 462 046 India. NDC 68180-723-20

Drugs Aphrodisiac Platinum 40000, Proprietary Raw

Material 6000 mg, 1 count blister

card, 24 cards per box, Distributed by: Aphrodisiac.

UPC Code 644118128135

Class II All lots Marketed without an approved

NDA/ANDA: FDA analysis has found the

product to be tainted with

sildenafil

SELECT DISTRIBUTIONS

LLC

Drugs PROCHLORPERAZINE EDISYLATE

INJECTION, USP 10 mg/2mL

(5mg/mL), 2mL Vial, Rx Only, Mfg

by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India. Mfg

for: Heritage Pharmaceuticals Inc. NDC 23155-

294-31

Class II Lot: VPCA172, EXP April 2020

Non-Sterility: Microbial growth detected in sub lot of Amikacin

Sulfate Injection, USP 1gm/4 mL

(250mg/mL) and Prochlorperazine

Edisylate Injection, USP

10mg/2mL (5mg/mL).


, Inc.

Drugs AMIKACIN SULFATE

INJECTION, USP, 1 gram/4 mL (250

mg/ml), 4 mL vial, Rx only, Mfd. by:

Emcure Pharmaceuticals, Ltd., Hinjawadi, Pune, India Mfd.

for: Heritage Pharmaceuticals

Class II Lot: VEAC025, EXP 10-2019

Non-Sterility: Microbial growth detected in sub lot of Amikacin

Sulfate Injection, USP 1gm/4 mL

(250mg/mL) and Prochlorperazine

Edisylate Injection, USP

10mg/2mL (5mg/mL).


, Inc.



Product Type

Product Description


Recalling Firm

Inc.. NDC 23155-290-32

Drugs Pecgen DMX Cough

Suppressant Expectorant,

Contains the same active ingredients as Trispec DMX,

Sugar Free, Alcohol Free, Dye Free, Gluten Free, Cherry Raspberry Flavor, 16 Fl. oz.

(474 mL), Manufactured in

the USA for Kramer Novis, San

Juan, PR 00917, www.kramernovis.com, NDC 52083-

630-16.

Class II Lot #s: D80202, D80210 Exp. 02/20; D80818, D80819 Exp. 09/20; D80820 Exp. 09/20

Labeling: Incorrect

Instructions; The product has been found to provide incorrect dosage information on

its label due to a typographical

error. The drug facts label

incorrectly states children 6 to

under 2 years of age, 1

teaspoonful every 4 hours,

not to exceed 4 teaspoonfuls in

24 hours or directed by

physician. The label should state

children 6 to under 12, 1 teaspoonful

every 4 hours, not to exceed 4 teaspoonfuls in 24 hours or as

directed by physician.

Additionally, the label does not

advise consumers to

consult a doctor for children

under 2 years of age.

Novis PR, Inc.

Drugs RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only,

Class II Lot #s: 18F020, Exp. 06/2020; 18H013, Exp. 08/2020; 18J015, Exp.

cGMP Deviations:

Potential product

Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

30 mL bottle, NDC 13668-589-06,

Manufactured by Bio-Pharm Inc., Levittown PA

19057, Manufactured for Torrent Pharma

Inc., Basking Ridge, NJ 07920.

09/2020; 18K015, 18K034, Exp. 10/2020; 19A014, Exp. 01/2021

contamination with

Burkholderia cepacia (B.

cepacia) and Ralstonia

pickettii (R. pickettii).

Drugs Children's Acetaminophen

Liquid, 160 mg per 5 mL, Fever and

Pain, Alcohol free, aspirin free,

ibuprofen free, Cherry Flavor, 4 FL. oz. (118 mL)

bottle, NDC: 59741-101-06,

Manufactured by Bio-Pharm, Inc.,

Levittown PA 19057, Assured.

Class II Lot #: 17E035, Exp. 05/2019

cGMP Deviations:

Potential product contamination

with Burkholderia cepacia (B.



Torrent Pharma Inc

Drugs Allergy Liquid Antihistamine,

Diphenhydramine HCl USP 12.5 mg/5 mL), Alcohol free, 4 FL. oz. (118 mL)

bottle, NDC: 59741-119-06,

Manufactured by Bio-Pharm Inc., Levittown, PA

19057, Assured.

Class II Lot #s: 17E019; 17E045, Exp. 05/2019

cGMP Deviations:





Torrent Pharma Inc

Drugs Children's Mapap Acetaminophen

Liquid, Fever reducer, Pain

reliever, Alcohol free, Aspirin free, Cherry flavored, acetaminophen

Class II Lot #s: a) 17E003; 17E038, Exp. 05/2019;

17F002; 17F005; 17F007; 17F025, Exp.

06/2019; 17G014, Exp. 07/2019; 17H015, Exp.

08/2019; 17J004; 17J006; 17J016, Exp.

cGMP Deviations:



cepacia) and

Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

160 mg per 5 mL, a) 4 FL. oz. (118 mL) bottle, NDC

0904-1985-20, b) One Pint (473 mL) bottle, NDC: 0904-

1985-16, Distributed by

Major Pharmaceuticals, Livonia MI 48152.

09/2019; 17K008; 17K013; 17K021;

17K027, Exp. 10/2019; 17L021, Exp. 11/2019; 17M032, Exp. 12/2019; 18A023; 18A039, Exp.

01/2020; 18B007; 18B030; 18B037, Exp.

02/2020; 18C017; 18C026, Exp. 03/2020; 18D003; 18D034, Exp.

04/2020; 18E027; 18E033, Exp. 05/2020; 18F024; 18F033, Exp.

06/2020; 18G001; 18G023, Exp. 07/2020;

18J008; 18J009; 18J017; 18J027, Exp.

09/2020; 18K013; 18K014; 18K028, Exp. 10/2020. b) 17E006; 17E008, Exp. 05/2019;

17G001; 17G008;17G025, Exp. 07/2019; 17J022, Exp.

09/2019; 17K001; 17K007; 17K007A, Exp.

10/2019; 17L014, 17L034, Exp. 11/2019; 18A007; 18A007A, Exp.

01/2020; 18A025; 18A036, Exp. 01/2020;

18B018; 18B033; 18B034, Exp. 02/2020; 18D032; 18D035, Exp.

04/2020; 18E006; 18E035; 18E036, Exp.

05/2020; 18F033; 18F034, Exp. 06/2020; 18G007; 18G019, Exp.

07/2020; 18H008; 18H009; 18H025, Exp. 08/2020; 19A002, Exp.

01/2021.

Ralstonia pickettii (R. pickettii).



Product Type

Product Description


Recalling Firm

Drugs Robafen Cough Formula

Expectorant (guaifenesin USP

200 mg in each 10 mL), a) 4 Fl. oz. (118 mL) bottle,

NDC: 0904-0061-00, b) One Pint (473 mL) bottle,

NDC: 0904-0061-16, Distributed by


Class II Lot #s: a) 17F003, Exp. 06/2019; 17J011, Exp.

09/2019; 17K018; 17K020, Exp. 10/2019; 17M014; 17M034, Exp. 12/2019; 18A035; Exp.

01/2020; 18B022; 18B027, Exp. 02/2020; 18C036, Exp. 03/2020; 18D009; 18D024, Exp. 04/2020. b) 17G018, Exp. 07/2019; 17H001; 17H010; 17H014, Exp. 08/2019; 17J009, Exp. 09/2019; 17K023, Exp.

10/2019; 17L006; 17L025, Exp. 11/2019; 17M025; 17M034; Exp.

12/2019; 18A005; 18A012; 18A016, Exp. 01/2020; 18B020, Exp.

02/2020; 18C023; 18C031, Exp. 03/2020; 18E017, Exp. 05/2020; 18G005; 18G022, Exp.

07/2020; 18H021; 18H026, Exp. 08/2020; 18J003Exp. 09/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Robafen AC Oral Solution

(Guaifenesin and Codeine

Phosphate Oral Solution, USP) 100

mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 0904-6479-16, Distributed by

Major Pharmaceuticals Inc., Livonia MI

48152.

Class II Lot #s: 17M003, Exp. 12/2019; 18A009;

18A010, Exp. 01/2020; 18B024, Exp. 02/2020; 18F021; Exp. 06/2020; 18G009; 18G020, Exp.

07/2020; 18K005; 18K011; Exp. 10/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Robafen DM Syrup

Class II Lot #s: a) 17F001, Exp. 06/2019; 17G016, Exp.

cGMP Deviations:

Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

(Dextromethorphan HBr, USP 20 mg/10 mL and

Guaifenesin, USP 200 mg/10 mL), a) 4 oz. bottle, NDC: 0904-0053-00, b) 8 oz. bottle, NDC: 0904-0053-09, c)

16 oz. bottle, NDC:0904-0053-

16, Distributed by Major

Pharmaceuticals Inc., Livonia MI

48152.

07/2019; 17H017, Exp. 08/2019;17L002;

17L024, Exp. 11/2019; 17M010; 17M013, Exp.

12/2019; 18B006; 18B031, Exp. 02/2020; 18C033, Exp. 03/2020; 18D015; 18D016, Exp. 04/2020; 18E020, Exp. 05/2020; 18G013, Exp. 07/2020; 18L010, Exp.

11/2020; 19A010; 19A019, Exp. 01/2021

b) 17F015, Exp. 06/2019; 17L009, Exp. 11/2019; 17M012, Exp. 12/2019; 18B015, Exp. 02/2020; 18C034, Exp. 03/2020; 18E026, Exp. 05/2020; 18G011, Exp. 08/2020. c) 17E014,

Exp. 05/2019; 17G009;17G020, Exp. 07/2019; 17K019, Exp.

10/2019; 17L012; 17L013, Exp. 11/2019; 17M016; 17M033, Exp. 12/2019; 18A002, Exp.

01/2020; 18B009; 18B019, Exp. 02/2020; 18C015; 18C035, Exp.

03/2020; 18D001; 18D002, Exp. 04/2020; 18E018, Exp. 05/2020; 18F027, Exp. 06/2020; 18H017; 18H018, Exp.

08/2020; 18K016; 18K035, Exp. 10/2020.





Drugs Banophen Oral Solution, Sugar

Free, Alcohol Free, Cherry Flavor,

(Diphenhydramine HCl, USP) Each

teaspoonful

Class II Lot #s: a)17E018; 17E020, 17E026, Exp.

05/2019; 17H008; 17H018; 17H028, Exp.

08/2019; 17J002; 17J025; 17J028, Exp.

09/2019; 17L035, Exp.

cGMP Deviations:



Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

contains diphenhydramine

hydrochloride, USP 12.5 mg, a) 4

Fl. oz. (118 mL) bottle, NDC: 0904-

1228-00, b) One Pint (473 mL)

bottle, NDC: 0904-5174-16,

Distributed by Major

Pharmaceuticals, Livonia MI 48152.

11/2019; 17M024, Exp. 12/2019; 18A017, Exp. 01/2020; 18B016, Exp. 02/2020; 18C011, Exp.

03/2020; 18D014; 18D021; 18D026, Exp. 04/2020; 18E014, Exp. 05/2020; 18F036, Exp.

06/2020; 18F035; 18G018, Exp. 07/2020; 18H005; 18H015, Exp.

08/2020; 19A011; 19A013, Exp. 01/2121.

b) 17E013; 17E025; 17E028; 17E041, Exp.

05/2019; 17F009; 17F016, Exp. 06/2019;

17G007; 17G021; 17G032, Exp. 07/2019; 17H023, Exp. 08/2019;

17J001; 17J012; 17J023; 17J027, Exp. 09/2019;

17K004; 17K022; 17K028; 17K028A, Exp. 10/2019; 17L032; Exp. 11/2019; 17M036, Exp.

12/2019; 18A011; 18A019; 18A030;

18A032; 18A041, Exp. 01/2020; 18B010;

18B038, Exp. 02/2020; 18C008; 18C022;

18C030, Exp. 03/2020; 18D004; 18D008;

18D010; 18D011, Exp. 04/2020; 18F028;

18H010, Exp. 06/2020; 18G004; 18G012, Exp.

07/2020; 18H002; 18H011; 18H027;

18H032; 18H033, Exp. 08/2020; 18K008;

18K009, Exp. 10/2020.



Drugs Pseudoephedrine Oral Solution, 30

Class II Lot #s: 17H012, Exp. 08/2019; 17L011, Exp.

cGMP Deviations:

Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

mg in each teaspoonful, Nasal

Decongestant, One Pint (473 mL) bottle, NDC: 0536-


Rugby Laboratories,

Livonia MI 48152.

11/2019; 17M020, Exp. 12/2019; 18D007, Exp. 04/2020; 18J001, Exp.

09/2020.





Drugs Nasal Decongestant Spray Regular, Oxymetazoline

HCl 0.05%, a) 0.5 FL. oz. (15 mL)

bottle, NDC:0904-5711-35, b) 1 FL.

oz. (30 mL) bottle, NDC: 0904-5711-30, Distributed by


Class II Lot #s: a) 17E032, Exp. 05/2019; 17F011;

17F020, Exp. 06/2019; 17G003; 17G011, Exp. 07/2019; 17H016, Exp.

08/2019; 17J005; 17J017; 17J026, Exp.

09/2019; 17K029, Exp. 10/2019; 17L027, Exp.

11/2019; 18A003; 18A004; 18A033, Exp. 01/2020; 18B011, Exp. 02/2020; 18C029, Exp.

03/2020; 18D019; 18D025, Exp. 04/2020; 18F014, Exp. 06/2020; 18H029, Exp. 08/2020; 18J007; 18J018, Exp.

09/2020; 18K007; 18K026, Exp. 10/2020; 19A012, Exp. 01/2021.

b) 17E011, Exp. 05/2019; 17E012, Exp.

06/2019; 17G019; 17G023, Exp. 07/2019; 17H011, Exp. 08/2019; 17J029, Exp. 09/2019; 17K005, Exp. 10/2019; 17M005; 17M018, Exp.

12/2019; 18C001; 18C004, Exp. 03/2020; 18F032; 18F019, Exp.

06/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Robafen DM Cough Sugar-Free

Class II Lot #s: 17E016; 17E017, Exp. 05/2019; 17F023;

cGMP Deviations:

Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

Clear Cough Expectorant

(Dextromethorphan HBr, USP 20

mg), Expectorant (Guaifenesin, USP 200 mg in each 2

teaspoonfuls (10mL)), 4 Fl. oz. (118 mL) bottle,



17F023A, Exp. 06/2019; 17L018; 17L029;

17L030; 17L031, Exp. 11/2019; 17M035, Exp.

12/2019; 18B002; 18B014; 18B035, Exp.

02/2020; 18C002; 18C019, Exp. 03/2020; 18D013, Exp. 04/2020.





Drugs Pedia Relief Cough-Cold Oral Solution, Alcohol

free, antihistamine,

cough suppressant, nasal

decongestant, Chlorpheniramine

Maleate, USP 2 mg;

Dextromethorphan HBr, USP 10 mg; Pseudoephedrine HCl, USP 30 mg in

each 2 tsp (10 mL)), 4 Fl. oz. (118

mL) bottle, NDC:0904-5050-

20, Distributed by Major

Pharmaceuticals, Livonia MI 48152.

Class II Lot #s: 17L020, Exp. 11/2019; 18C025, Exp. 03/2020; 18J020, Exp.

09/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Biscolax Laxative (Bisacodyl, USP 10

mg), a) 12 suppositories per

carton, NDC: 0904-5058-12, b) 100 suppositories

Class II Lot #s: a) 17E004; 17E033, Exp. 05/2019; 17F019, Exp. 06/2019; 17G017, Exp. 07/2019; 17K009; 17K030; Exp.

10/2019, 17M006; 17M028, Exp. 12/2019;

cGMP Deviations:



Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

per carton, NDC: 0904-5058-60, Distributed by

Major Pharmaceuticals Inc., Livonia MI

48152.

18A029, Exp. 01/2020; 18C037, Exp. 03/2020; 18E002, Exp. 05/2020; 18F003; 18F013, Exp.

06/2020; 18G002; 18G016, Exp. 07/2020; 18H031, Exp. 08/2020;

18J004, 09/2020; 18L008; 18L012, Exp.

11/2020; 19A008, Exp. 01/2021. b) 17E005; 17E027, Exp. 05/2019; 17K025, Exp. 10/2019; 17M006, Exp. 12/2019; 18A014, Exp. 01/2020; 18B039, Exp. 02/2020; 18C037, Exp. 03/2020; 18D033, Exp. 04/2020; 18E025, Exp. 05/2020; 18F013; 18F018, Exp.

06/2020; 18G003, Exp. 07/2020; 18H012;

18H014, Exp. 08/2020; 18J026, Exp. 09/2020; 18L009, Exp. 11/2020; 18M014, Exp. 12/2020; 19A021, Exp. 01/2021; 19B001; 19B002, Exp.

02/2021.



Drugs Cyproheptadine Hydrochloride

Syrup Oral Solution, USP,

2mg/5mL, 473 mL (16 FL. oz.) bottle, NDC: 39328-044-

16, Patrin Pharma, Skokie, IL 60076.

Class II Lot #s: 17L003, Exp. 05/2019; 18A021, Exp. 07/2019; 18C027, Exp. 09/2019; 18D020, Exp.

10/2019; 18E007, 18E022, Exp. 11/2019;

18F006; 18F007; 18F023; 18F023A;

18F040, Exp. 12/2019; 19A004, Exp. 07/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Hyoscyamine Oral Drops 0.125

mg/mL, Rx Only, 15 mL bottle (0.5

FL. oz.), NDC:

Class II Lot #s: 17E039, Exp. 05/2019; 17K016, Exp. 10/2019; 18E021, Exp. 05/2020; 18G008, Exp.

07/2020.

cGMP Deviations:


with

Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

39328-047-15, Manuf. for Patrin Pharma, Skokie IL

60076.

Burkholderia cepacia (B.



Drugs Hyoscyamine Sulfate Elixir 0.125

mg per 5 mL, Rx Only, 473 mL (16 oz.) bottle, NDC: 39328-048-16, Patrin Pharma,

Skokie IL 60076.

Class II Lot #s: 17F021, Exp. 06/2019; 17G013, Exp. 07/2019; 17K010, Exp. 10/2019; 18E015, Exp.

05/2020; 18F029; 18F031; 18F042, Exp.

06/2020; 18G024, Exp. 07/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Cetirizine HCL Oral Solution, USP

1mg/mL, 4 oz - BULK, PLD

Class II Lot #s: 17E015; 17E024; 17E044, Exp. 05/2019; 17F018, Exp. 06/2019; 17G012, Exp. 07/2019; 17K024, Exp. 10/2019; 17M004, Exp. 12/2019; 18B017, Exp. 02/2020; 18H023, Exp. 08/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Acetic Acid Otic Solution, USP, 2%,

Rx Only, 15 mL bottle, NDC:

64980-424-15, Manufactured by Bio-Pharm Inc., Levittown, PA

19057, Distributed by Rising

Pharmaceuticals Ins Saddie Brook,

NJ 07663.

Class II Lot #s: 18J005; 18J016; 18J025, Exp. 09/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Guaifenesin AC Cough Syrup

(Guaifenesin and Codeine

Class II Lot #s: 17H002; 17H005; 17H006; 17H007;

17H026; 17H027, Exp. 08/2019; 17J010;

cGMP Deviations:


Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

Phosphate Oral Solution, USP) 100

mg/10 mg per 5 mL, One Pint (473 mL) bottle, NDC: 16571-302-16, Distributed by

Rising Pharmaceuticals

Inc., Saddle Brook, NJ 07663

17J013, Exp. 09/2019; 17K014; 17K015, Exp. 10/2019; 17L015, Exp. 11/2019; 17M026, Exp.

12/2019; 18A028; 18A031, Exp. 01/2020; 18B026, Exp. 02/2020; 18E003, Exp. 05/2020.




Drugs Guaifenesin DAC Oral Solution,

Sugar free, (Guaifenesin,

Pseudoephedrine HCl and Codeine Phosphate Oral Solution, USP),

Expectorant, Nasal Decongestant,

Cough Suppressant, 100 mg/30 mg/10 mg

per 5 mL, One Pint (473 mL) bottle,

NDC: 16571-301-16, Manufactured by Bio-Pharm Inc.,

Levittown, PA 19057, Distributed

by Rising Pharmaceuticals

Inc., Allendale, NJ 07401.

Class II Lot #s: 17E031, Exp. 05/2019; 18F030, Exp.

06/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Phenobarbital Oral Solution,

USP, 20 mg per 5 mL, Rx Only, One

Pint (473 mL) bottle,

NDC:16571-330-16, Manufactured by Bio-Pharm Inc.,

Levittown, PA

Class II Lot #s: 17E007, Exp. 05/2019; 17F026, Exp. 06/2019; 17G015, Exp.

07/2019; 17K002; 17K026, Exp. 10/2019; 17M002, Exp. 12/2019; 18C020, Exp. 03/2020; 18D023, Exp. 04/2020; 18F009, Exp. 06/2020; 18K030, Exp. 10/2020.

cGMP Deviations:




pickettii (R.

Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

10957, Distributed by Rising

Pharmaceuticals Inc., Saddle Brook,

NJ 07663.

pickettii).

Drugs Pain & Fever Oral Solution

(Acetaminophen 160 mg/5 mL),

Sugar free, Aspirin & Alcohol free,

Cherry flavored, a) 4 Fl. oz. bottle, NDC: 0536-0122-97, b) One Pint (473 mL) bottle,


Rugby Laboratories,

Lavonia, MI 48152 USA.

Class II Lot #s: a) 17E022; 17E037, Exp. 05/2019; 17G006; 17G026, Exp.

07/2019; 17H019; 17H020, Exp. 08/2019; 17J020, Exp. 09/2019; 17K006; 17K012, Exp.

10/2019; 17L028; 17L033, Exp. 11/2019;

18A001; 18A006; 18A013; 18A038, Exp. 01/2020; 18B036, Exp. 02/2020; 18C024, Exp.

03/2020; 18E009; 18E019; 18E028, Exp. 05/2020; 18F010, Exp. 06/2020; 18H003, Exp.

08/2020; 18J010; 18J012; 18J013; 18J019, Exp. 09/2020; 18K003; 18K012, Exp. 10/2020; 19A016, Exp. 01/2021.

b) 17E036, Exp. 05/2019; 17F008;

17F008A, Exp. 06/2019; 17H030, Exp. 08/2019; 17K017, Exp. 10/2019; 17L017, Exp. 11/2019; 17M031, Exp. 12/2019; 18A020; 18A040, Exp. 01/2020; 18B036, Exp. 02/2020; 18C032, Exp.

03/2020; 18E004; 18E032, Exp. 05/2020; 18F001, Exp. 06/2020; 18H006, Exp. 08/2020; 18K032, Exp. 10/2020; 18L003, Exp. 11/2020; 19A007, Exp. 01/2021.

cGMP Deviations:





Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

Drugs Kid Kare Childrens Cough/Cold

Liquid, Antihistamine,

Cough Suppressant,

Nasal Decongestant,

Cherry Flavored, Alcohol Free,

(Chlorpheniramine Maleate, USP 2

mg, Dextromethorphan HBr, USP 10 mg, Pseudoephedrine HCl, USP 30 mg in

each 2 tsp (10mL)), 4 Fl. oz.

bottle, NDC: 0536-2310-97,

Distributed by Rugby

Laboratories, Livonia MI 48152.

Class II Lot #s: 17E009, Exp. 05/2019; 17L004;

17L004A, 17L020, Exp. 11/2019; 17M029, Exp.

12/2019; 18C010; 18C025, Exp. 03/2020; 18J020, Exp. 09/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Cough Syrup (Guaifenesin

Syrup, USP) 200 mg/10 mL, Alcohol free Non-Narcotic Expectorant, One Pint (473 mL) oz.

bottle, NDC: 0536-0825-85,

Distributed by Rugby

Laboratories, Livonia, MI 48152.

Class II Lot #s: 17F022, Exp. 06/2019; 17G027, Exp.

07/2019; 17H021; 17H021A, Exp. 08/2019; 17J008, Exp. 09/2019; 17L001, Exp. 11/2019; 17M015, Exp. 12/2019; 18A018, Exp. 01/2020; 18B003; 18B008, Exp. 02/2020; 18C012, Exp. 03/2020; 18D005, Exp.

04/2020; 18F008; 18F043, Exp. 06/2020; 18G025; 18H004, Exp.

07/2020; 18H007; 18H016, Exp. 08/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Extra Action Cough Syrup

(Guaifenesin and Dextromethorpha

Class II Lot #s: 17E034, Exp. 05/2019; 17L023, Exp.

11/2019; 17M027; 17M027A, Exp. 12/2019;

cGMP Deviations:


Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

n HBr Syrup) 100 mg/10 mg per 5 mL, a) 4 FL. oz.

(118 mL) bottle, NDC: 0536-0970-97, b) One Pint (473 mL) bottle, 0536-0970-85, Distributed by

Rugby Laboratories,

Livonia, MI 48152.

18A024, Exp. 01/2020; 18B029, Exp. 02/2020; 18C018; 18C021, Exp. 03/2020; 18E008, Exp.

05/2020.




Drugs Diphenhist Oral Solution

(Diphenhydramine HCl, USP), 12.5

mg/5 mL, a) 4 FL. oz. (118 mL)

bottle, NDC: 0536-0770-97, b) One

Pint (473 mL) bottle, NDC: 0536-


Rugby Laboratories,

Livonia, MI 48152.

Class II Lot #s: a) 17H025, Exp. 08/2019; 17M022, Exp. 12/2019; 18E011, Exp. 05/2020; 18G018, Exp. 07/2020; 18J014, Exp. 09/2020. b) 17E010; 17E030, Exp. 05/2019; 17F013, Exp. 06/2019; 17F010, Exp. 07/2019; 17J014, Exp. 09/2019; 17L005, Exp. 11/2019; 17M017, Exp. 12/2019; 18A022, Exp. 01/2020; 18B021, Exp. 02/2020 18D017, Exp. 04/2020; 18E011, Exp. 05/2020; 18F041, Exp. 06/2020;

18G021; 18H022; 18H028; 18H030, Exp.

08/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Nasal Decongestant

Liquid, Pseudoephedrine HCl, 30 mg in each teaspoonful, 4 Fl.

oz. (118 mL) bottle, NDC:0536-


Rugby Laboratories,

Livonia MI 48152.

Class II Lot #s: 17G002, Exp. 07/2019; 17H024, Exp. 08/2019; 17M023, Exp. 12/2019; 18F012, Exp.

06/2020.

cGMP Deviations:





Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

Drugs Lactulose Solution, USP 10 g/15 mL, For Oral Administration, Rx Only, a) 16 FL. oz., NDC: 13668-580-10, b) 32 FL. oz., NDC: 13668-580-12, Manufactured by Bio-Pharm Inc.,

Levittown PA 19057,

Manufactured for Torrent Pharma


Class II Lot #s: a) 18K025; 18K027, Exp. 10/2020;

18L001; 18L006; 18L007, Exp. 11/2020; 18M013, Exp. 12/2020; 19A006, Exp. 01/2021.

b) 18K027, Exp. 10/2020; 19A006, Exp.

01/2021.

cGMP Deviations:





Torrent Pharma Inc

Drugs Lactulose Solution, USP 10 g/15 mL, For Oral

or Rectal Administration, Rx

Only, 16 FL. oz. Bottle, NDC:

13668-574-10, Manufactured By

Bio-Pharm, Levittown, PA

19057, Manufactured for Torrent Pharma


Class II Lot #s: 18E016; 18E029, Exp. 05/2020; 18F004; 18F005; 18F039, Exp.

06/2020; 18G010; 18G017, Exp. 07/2020; 18H019, Exp. 08/2020; 18M008, Exp. 12/2020; 19A005, Exp. 01/2021; 19B010, Exp. 02/2021.

cGMP Deviations:





Torrent Pharma Inc

Drugs Memantine Hydrochloride

Oral Solution, 2 mg/mL, 12 oz. bottle, NDC:

39328-551-12, Patrin Pharma

Class II Lot #s: 17E001, Exp. 05/2019; 17F014, Exp.

06/2019; 17G005; 17G010, Exp. 07/2019; 17J019; 17J021, Exp. 09/2019; 17M008;

17M009, Exp. 12/2019.

cGMP Deviations:





Torrent Pharma Inc

Drugs Memantine Hydrochloride

Class II Lot #: 18F026, Exp. 06/2020.

cGMP Deviations:

Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

Oral Solution, 2 mg/mL, Rx Only, 12 FL. oz bottle,

NDC: 13668-573-09, Manufactured By Bio-Pharm Inc.,

Levittown, PA 19057,

Manufactured for Torrent Pharma






Drugs Hydrocortisone Acetate

Suppositories, 25 mg, Rx Only, For

rectal administration, a)

12 Adult Suppositories per

carton, NDC: 59741-301-12, b)

24 Adult Suppositories per

carton, NDC: 59741-301-24,

Manufactured by Bio-Pharm Inc., Levittown PA

19057.

Class II Lot #s: a) 17L010, Exp. 11/2019; 18D018, Exp.

04/2020; 18F022; 18F022A, Exp. 06/2020. b) 17L019; 17L026, Exp. 11/2019; 18B005, Exp.

02/2020; 18D006, 18D012; 18D022, Exp. 04/2020; 18K006, Exp.

10/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Laxative Suppositories

(Bisacodyl USP, 10 mg), a) 12

Suppositories per carton, NDC:

0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01,

Distributed Rugby Laboratories,

Livonia, MI 48152.

Class II Lot #s: a) 17K009, Exp. 10/2019; 17M028, Exp. 12/2019; 18F003, Exp. 06/2020; 18J022, Exp. 09/2020; 18L012, Exp. 11/2020; 19A008, Exp. 01/2021. b) 17G004; 17G028, Exp. 07/2019; 18A034, Exp. 01/2020; 18C016, Exp. 03/2020; 18E005, Exp. 05/2020; 18F038, Exp. 06/2020; 18G015, Exp. 07/2020; 18H024, Exp. 08/2020; 18K024, Exp. 10/2020;

cGMP Deviations:





Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

18L011, Exp. 11/2020; 19A009, Exp. 01/2021; 18D033, Exp. 04/2020; 18E025, Exp. 05/2020.

Drugs Hemorrhoidal Suppositories

(Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12

Rectal Suppositories per

carton, NDC: 0536-1389-12, Distributed by

Rugby Laboratories,

Livonia MI 48152 USA.

Class II Lot #s: 17L008, Exp. 05/2019; 17M019;

17M037, Exp. 06/2019; 18B012; 18K023, Exp.

04/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Anu-Med brand of Hemorrhoidal Suppositories

(Phenylephrine HCl 0.25%; Hard Fat 88.7%), 12

suppositories per carton, NDC:

0904-7688-22, Distributed by


Class II Lot #s: 17L008, Exp. 05/2019; 17M011;

17M037, Exp. 06/2019; 18A015, Exp. 07/2019; 18B012; 18B023, Exp.

08/2019; 18K023; 18K029, Exp. 04/2020; 18L014, Exp. 05/2020; 19A001, Exp. 06/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Cetirizine Hydrochloride

Oral Solution, USP 1 mg/mL, For Oral Use Only, Rx Only,

120 mL bottle, NDC 23155-292-

51, Mfd for Heritage

Pharmaceuticals Inc., Eatontown,

NJ 07724.

Class II Lot #s: 17E021; 17E023; 17E040; 17E042, Exp. 05/2019; 17F017, Exp.

06/2019; 17G030; 17G033, Exp. 07/2019; 17H013, Exp. 08/2019; 17J007; 17J024, Exp.

09/2019; 17K003; 17K011, Exp. 10/2019; 17L016; 17L022, Exp.

11/2019; 17M001; 17M021; 17M030, Exp.

12/2019; 18A027; 18A037, Exp. 01/2020;

cGMP Deviations:





Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

18B001, Exp. 02/2020; 18C005; 18C006;

18C007, Exp. 03/2020.

Drugs Cetirizine Hydrochloride

Oral Solution, USP 1mg/mL, Fr Oral

Use Only, Rx only, 120 mL bottle, a) NDC 13668-029-

07, b) NDC 13668-596-07,

Manufactured by Bio-Pharm, Inc.

Levittown, PA, For Torrent Pharma


Class II Lot #s: a) Lot #: 18D027, 18D028, 18D029; Exp.

04/2020. b) 18D029A, Exp. 04/2020; 18E001B; 18E010B, Exp. 05/2020;

18F016A; 18F017A; 18F037A, Exp. 06/2020;

18J021; 18J023; 18J023A; 18J024, Exp.

09/2020; 18K001; 18K002, Exp. 10/2020; 19A003; 19A022, Exp. 01/2021; 19B009, Exp.

02/2021.

cGMP Deviations:





Torrent Pharma Inc

Drugs RisperiDONE Oral Solution, USP, 1 mg/mL, Rx Only,

30 mL bottle, NDC 23155-317-51,

Mfd for Heritage Pharmaceuticals

Inc., East Brunswick, NJ

08816.

Class II Lot #s: 17F012; 17F012A, Exp. 06/2019; 17G031, Exp. 07/2019; 17H004; 17H031, Exp. 08/2019; 18B004, Exp. 02/2020; 18C028, Exp.

03/2020

cGMP Deviations:





Torrent Pharma Inc

Drugs Hydrocodone Bitartrate and Homatropine

Methylbromide Oral Solution, 5

mg/1.5 mg per 5 mL, Rx Only, 16 FL.

oz. (473 mL) bottle, NDC:

59741-262-16 Manufactured by Bio-Pharm Inc., Levittown, PA

19057 USA.

Class II Lot #s: 18B013, Exp. 02/2020; 18E024;

18E030, Exp. 05/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Hydrocodone Bitartrate and

Class II Lot #s: 18E034, Exp. 05/2020; 19A015, Exp.

cGMP Deviations:

Torrent Pharma Inc



Product Type

Product Description


Recalling Firm

Homatropine Methylbromide Oral Solution, 5

mg/1.5 mg per 5 mL, Rx Only, 16 FL.

oz. (473 mL) bottle,

NDC:13668-577-10 Distributed by Torrent Pharma


01/2021. Potential product contamination




Drugs Bisacodyl Suppositories,

Brite Stock, Reese.

Class II Lot #s: 17J003, Exp. 09/2019; 18A026, Exp. 01/2020; 18E031, Exp.

05/2020.

cGMP Deviations:





Torrent Pharma Inc

Drugs Bacteriostatic Water for

Injection, 10 mL vials, Pharm D. Solutions 1304

South Loop West, Houston, TX

77054, 1-844-263-6846

Class II Lot #: 11292018:75 Exp. 05/28/2019;

01022019:70 Exp. 07/01/2019;

02042019:04 Exp. 08/03/2019;

03042019:94 Exp. 08/31/2019

Lack of Sterility Assurance.

Pharm D Solutions, LLC

Drugs B-complex (Thiamine 100mg,

Riboflavin 2mg, Niacinamide 100 mg, Pyridoxine

2mg, Depanthenol 5mg) injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304


77054, 1-844-263-

Class II Lot #: 04032019:23 Exp. 06/11/2019





Product Type

Product Description


Recalling Firm

6846, NDC 69699-1611-30

Drugs Human Chorionic Gonadotropin

10,000 IU vials, Rx only Pharm D. Solutions 1304


77054, 1-844-263-6846

Class II Lot #: 02052019:42 Exp. 08/03/2019



Drugs Human Chorionic Gonadotropin

5,000 IU vials, Rx only, Pharm D. Solutions 1304


77054, 1-844-263-6846

Class II Lot #: 01082019:88 Exp. 07/06/2019;

03182019:58 Exp. 09/14/2019



Drugs Human Chorionic Gonadotropin 12,000 IU vials

Pharm D. Solutions 1304


77054, 1-844-263-6846

Class II Lot #: 01232019:86 Exp. 07/22/2019;

04042019:86 Exp. 10/01/2019



Drugs Ipamorelin Acetate 9 mg/9mL Injectable vials, Rx

only, Pharm D. Solutions 1304


77054, 1-844-263-6846

Class II Lot #: 05022019:50 Exp. 10/29/2019;

05082019:91 Exp. 06/08/2019



Drugs Lipo MIC-12 (Methylcobalamin

, USP 1mg, Methionine USP 15mg, Inositol,

FCC 50mg, Choline Chloride, FCC 100

Class II Lot #: 02202019:53/A Exp. 08/18/2019; 04012019:67/A,

04022019:47/A Exp. 09/28/2019;

04042019:04/A Exp. 09/30/2019;





Product Type

Product Description


Recalling Firm

mg) 10 mL Injectable vials,



77054, 1-844-263-6846

04082019:38/A Exp. 10/02/2019;

04302019:49/A Exp. 10/27/2019;

05062019:09 Exp. 11/02/2019

Drugs Nandrolone Decanoate 200

mg/mL Injectable, 10 mL vials, Rx only, Pharm D. Solutions 1304


77054, 1-844-263-6846

Class II Lot #: 01312019:34 Exp. 07/30/2019



Drugs Sermorelin/Ipamorelin 18 mg/15

mg, 10mL vials, Rx only, Pharm D. Solutions 1304


77054, 1-844-263-6846

Class II Lot #: 04162019:48 Exp. 10/13/2019;

04302019:70 Exp. 10/27/2019;

05022019:34 Exp. 10/29/2019



Drugs Sermorelin/GHRP-2 9 mg/9 mg vials



77054, 1-844-263-6846

Class II Lot #: 05082019:92 Exp. 06/04/2019



Drugs Sermorelin/GHRP-2 9 mg/6 mg vials, Rx only, Pharm D.

Solutions 1304 South Loop West,

Houston, TX 77054, 1-844-263-

6846

Class II Lot #: 03052019:43 Exp. 08/31/2019;

04042019:15 Exp. 10/01/2019;

04172019:08 Exp. 08/31/2019;

05022019:47 Exp. 10/30/2019;

05082019:78 Exp. 06/04/2019





Product Type

Product Description


Recalling Firm

Drugs Sermorelin/GHRP-2 & 6 (3-3-3 MG) vials, Pharm D. Solutions 1304


77054, 1-844-263-6846

Class II Lot #: 12062018:17 Exp. 06/04/2019



Drugs Sermorelin/GHRP-2 &6 (9-9-9-mg) vials, Pharm D. Solutions 1304


77054, 1-844-263-6846

Class II Lot #: 05032019:29 Exp. 11/02/2019



Drugs Sermorelin/GHRP-2 &6 (9-9-9 mg) vials, Pharm D. Solutions 1304


77054, 1-844-263-6846

Class II Lot #: 02182019:79 Exp. 08/17/2019;

04162019:86 Exp. 10/13/2019



Drugs Testosterone 200 mg/mL, 30 mL vials, Rx only,



77054, 1-844-263-6846, NDC 69699-

1702-30

Class II Lot #: 10242018:70/B Exp. 08/31/2019;

10302018:63/A Exp. 08/31/2019



Drugs Testosterone Cyp/Pro 95/5%, 10 mL vials, Rx only,



77054, 1-844-263-6846

Class II Lot #: 01312019:02 Exp. 08/16/2019;

02072019:45/A Exp. 11/30/2019



Drugs Testosterone Cypionate 200

Class II Lot #: a) 10242018:70/P, Exp. 08/31/2019; b)





Product Type

Product Description


Recalling Firm

mg/mL, in a) 5mL vials and b)10 mL

vials, Rx only, Pharm D.

Solutions 1304 South Loop West,

Houston, TX 77054, 1-844-263-6846, NDC 69699-

1702-10

10242018:70/A Exp. 08/31/2019;

02262019:49/A Exp. 11/30/2019

Drugs Trimix 30mg/1 mg/10mcg/mL (

30 mg Papaverine, 1mg

phentolamine mesylate, 30 mcg

alprostadil) Injectable, 5mL vials, Rx only,



77054, 1-844-263-6846

Class II Lot #: 05022019:90 Exp. 07/13/2019



Drugs ZYFLO CR (zileuton)

extended-release tablets, 600 mg,

120-count bottles, Rx only,

Distributed by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-902-

12.

Class II Lots: 3171855, Exp. 12/19

Failed Dissolution Specifications:

Out of specification

result for dissolution.

Chiesi USA, Inc.

Drugs Zileuton Extended-Release Tablets, 600 mg,

120-count bottles, Rx only,

Distributed by: Prasco

Laboratories, Mason, OH 45040

Class II Lots: 3171856, Exp. 12/19

Failed Dissolution Specifications:

Out of specification

result for dissolution.

Chiesi USA, Inc.



Product Type

Product Description


Recalling Firm

USA; NDC 66993-485-32.

Drugs Estradiol Vaginal Inserts USP 10

mcg, packaged in box of 8 Vaginal

Inserts (with disposable

applicators), Rx Only,

Manufactured by: Glenmark

Pharmaceuticals Ltd. Colvale-

Bardez, Goa 403 513 India,

Manufactured for: Glenmark

Pharmaceuticals Inc., Mahwah, NJ 07430 USA, NDC

68462-711-71

Class II Lot#: 20180516, Exp 4/30/2020

Defective Delivery System: Estradiol Vaginal

Inserts USP plunger is not

functioning properly.

Glenmark Pharmaceuticals

Inc., USA

Drugs Heparin Sodium 25,000 USP units per 250 mL (100

USP units per mL) in 5% Dextrose

Injection, 250 mL EXCEL Container bag, Rx only, B. Braun Medical

Inc., Bethlehem, PA 18018-3524 USA, API from

SPAIN, NDC 0264-9587-20.

Class III Lot #: J7B259, Exp 31 Aug 2019

Subpotent Drug: low out-of-

specification results were

identified for the drug anti-factor

IIa potency which is intended to

ensure that the potency of

heparin is within the USP

specifications.

B. Braun Medical Inc

Drugs Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL

vial, Rx Only, Fresenius Kabi USA, LLC, Lake

Zurich, IL 60047, NDC 63323-374-

20

Class III Lot #: 6018699, Exp. 12/2021

Failed Impurities/Degra

dation Specifications.

Fresenius Kabi USA, LLC



*Please refer to FDA website for further information at: http://www.fda.gov/Safety/Recalls/default.htm



CURRENT DRUG SHORTAGES

25% Dextrose Injection May 23, 2019 Reasons for the Shortage

Pfizer has 25% dextrose on shortage due to manufacturing delays.

Estimated Resupply Dates Pfizer has 25% dextrose 10 mL Ansyr syringes on back order and the company estimates a release

date of August 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=483 50% Dextrose Injection May 23, 2019 Reasons for the Shortage

Amphastar has 50% dextrose injection on allocation due to increased demand.

Pfizer has 50% dextrose injection on shortage due to manufacturing delays.

Estimated Resupply Dates Pfizer has 50% dextrose 50 mL LifeShield syringes on back order and the company estimates a

release date of August 2019. The 50% dextrose 50 mL Ansyr syringes are on back order and the company estimates a release date of August 2019. The 50% dextrose 50 mL vials are on back order and the company estimates a release date of August 2019.

Amphastar has 50% dextrose 50 mL Luer-Jet syringes on allocation with regular releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=306 Fentanyl Citrate Injection May 23, 2019 Reasons for the Shortage

Akorn has fentanyl injection on shortage due to increased demand. They are not currently marketing 25 count fentanyl ampules.

Hikma has fentanyl injection on shortage due to supply and demand issues. They are not currently marketing fentanyl ampules, just vials.

Pfizer has fentanyl injection on shortage due to manufacturing delays. The 20 mL ampules were discontinued in September 2017.

Estimated Resupply Dates Pfizer has fentanyl 50 mcg/mL 2 mL and 20 mL vials on back order and the company estimates a

release date of August 2019. The 50 mL vials are available in limited supply The 2 mL Carpuject syringes are on back order and the company estimates a release date of October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=315






Vitamin K (Phytonadione) Injection May 23, 2019 Reasons for the Shortage

Pfizer has vitamin K injection on shortage due to manufacturing delays. Additional information on the yellow fever shortage is available at http://wwwnc.cdc.gov/travel/news-announcements/yellow-fever-vaccine-shortage-2015.

Estimated Resupply Dates

Pfizer has phytonadione 10 mg/mL 1 mL ampules available in limited supply. There are short-dated 1 mg/mL 0.5 mL ampules available in limited supply,

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=566 Copper Chloride Injection May 26, 2019 Reasons for the Shortage

Pfizer has copper chloride on shortage due to manufacturing delays. They are the sole supplier of copper chloride.

Estimated Resupply Dates Pfizer has copper chloride available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=553 Diazepam Injection May 26, 2019 Reasons for the Shortage

Pfizer has diazepam on shortage due manufacturing delays.

DASH Pharmaceuticals launched diazepam injection in early-April 2019.

Estimated Resupply Dates Pfizer has diazepam 5 mg/mL 2 mL Carpuject syringes available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=330 Diazepam Hydrochloride Injection May 26, 2019 Reasons for the Shortage

Akorn states the reason for the shortage was increased demand due to market conditions. They are not currently producing the 25 mL vials in 10 count.

Pfizer states the reasons for the shortage is manufacturing delays and increases in demand.

Hikma has diltiazem injection on shortage due to manufacturing delays caused by increased demand due to current market conditions.

Estimated Resupply Dates Hikma has diltiazem 5 mg/mL 25 mL vials on allocation.

Pfizer has 100 mg ADD-Vantage vials on back order and the company estimates a release date of June 2019. The 5 mg/mL 5 mL and 10 mL vials are also on back order and the company estimates a release date of March 2020 for the 5 mL vials and August 2019 for the 10 mL vials.








Diphenhydramine Injection May 26, 2019 Reasons for the Shortage

Fresenius Kabi has diphenhydramine injection available.

Hikma did not provide a reason for the shortage.

Mylan refuses to provide availability information.

Pfizer has diphenhydramine injection on shortage due to manufacturing delays.


Pfizer has diphenhydramine 50 mg/mL 1 mL vials on back order and the company estimates a release date of September 2019

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=456 Potassium Acetate Injection May 26, 2019 Reasons for the Shortage

American Regent has not had product available for several years. It is unclear if they will market potassium acetate again in the future.

Pfizer has potassium acetate on shortage due to manufacturing delays.

Estimated Resupply Dates Pfizer has potassium acetate 2 mEq/mL 50 mL vials on back order and the company estimates a

release date of August 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=344 Potassium Phosphate Injection May 26, 2019 Reasons for the Shortage

American Regent has not had potassium phosphate injection available since 2012. It is unclear if and when product will return to market.

Fresenius Kabi had potassium phosphate injection on shortage due to increased demand.

Pfizer had potassium phosphate injection on shortage due to manufacturing delays.

Estimated Resupply Dates Pfizer has potassium phosphate 3 mmol/mL 15 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=305 Remifentanil Injection May 26, 2019 Reasons for the Shortage

Mylan Institutional refuses to provide availability information.

Fresenius Kabi launched generic remifentanil in January 2018.

Estimated Resupply Dates Fresenius Kabi has remifentanil 2 mg and 5 mg vials on back order and the company estimates a

release date of early-July 2019.




Acetazolamide Injection May 28, 2019 Reasons for the Shortage



X-Gen had acetazolamide on shortage due to manufacturing delays.

Estimated Resupply Dates Hikma has acetazolamide 500 mg vials on back order and the company estimates a release date

of June 2019. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=528 Acetylcysteine Oral and Inhalation Solution May 28, 2019 Reasons for the Shortage

American Regent has acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

Arbor discontinued Cetylev effervescent tablets in April 2019.

Fresenius Kabi has acetylcysteine oral and inhalation solution available.

Pfizer had acetylcysteine oral and inhalation solution on shortage due to manufacturing delays.

Roxane Labs discontinued acetylcysteine oral and inhalation solution in April 2014.

Estimated Resupply Dates American Regent has acetylcysteine solution 200 mg/mL 30 mL vials on back order and the company

cannot estimate a release date.

Fresenius Kabi has short-dated acetylcysteine 100 mg/mL 4 mL and 30 mL vials available with an expiration date of <5 months.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=43 Argatroban Injection May 28, 2019 Reasons for the Shortage

AuroMedics did not provide a reason for the shortage.

Chiesi has argatroban temporarily unavailable. They are in the process of transferring the product to another company.

Fresenius Kabi has argatroban available.



Par has argatroban available.

Pfizer had argatroban on shortage due to manufacturing delay.

Sandoz discontinued argatroban 1 mg/mL 50 mL vials in April 2019.

Teva has argatroban temporarily unavailable.

Estimated Resupply Dates AuroMedics has argatroban 1 mg/mL 50 mL vials on intermittent back order.

Hikma has argatroban 1 mg/mL 50 mL vials and 100 mg/mL 2.5 mL vials on allocation.




Buprenorphine Hydrochloride Injection May 28, 2019 Reasons for the Shortage

Pfizer has buprenorphine injection on shortage due to manufacturing delays.

Par had buprenorphine injection on shortage due to increased demand.

Estimated Resupply Dates Pfizer has buprenorphine 0.3 mg/mL 1 mL Carpuject syringes on back order and the company

estimates a release date of September 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=419 Cefuroxime Sodium Injection May 28, 2019 Reasons for the Shortage

Sagent has cefuroxime injection on shortage due to manufacturing delays.

Teligent discontinued all Zinacef presentations in February 2018.

Hikma did not provide a reason for the cefuroxime injection shortage. They are not currently marketing the 7.5 gram vials.

Estimated Resupply Dates Sagent has cefuroxime 750 mg and 1.5 gram vials on back order and the company estimates a

release date of June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=13 Cyclosporine Injection May 28, 2019 Reasons for the Shortage

Novartis has Sandimmune available. Perrigo has cyclosporine injection available.


Perrigo has cyclosporine 50 mg/mL 5 mL ampules on back order and the company estimates a release date of early-July 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=534 Furosemide Tablets May 28, 2019 Reasons for the Shortage

Major discontinued furosemide tablets in early-2018.


Hikma states the shortage is due to manufacturing delays.

Sandoz discontinued furosemide tablets in late-August 2017.

Teva discontinued furosemide tablets in June 2018

Estimated Resupply Dates Hikma has furosemide 20 mg tablets in 100 count unit dose packs, 20 mg tablets in 100 count and

1,000 count bottles, 40 mg tablets in 100 count unit dose packs, 40 mg tablets in 100 count and



1,000 count bottles, 80 mg tablets in 100 count bottles, and 80 mg tablets in 100 count unit dose packs on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=339 Ketamine Injection May 28, 2019 Reasons for the Shortage



Par has Ketalar on shortage due to increased demand.

Pfizer has ketamine on shortage due to manufacturing delays.

Estimated Resupply Dates Hikma has ketamine 50 mg/mL 10 mL and 100 mg/mL 5 mL vials on allocation.

Pfizer has ketamine 50 mg/mL 10 mL vials on back order and the company estimates a release date of January 2020. The 100 mg/mL 5 mL vials are on back order and the company estimates a release date of April 2020.

Par has Ketalar 10 mg/mL 20 mL vials, 50 mg/mL 10 mL vials, and 100 mg/mL 5 mL vials on intermittent back order with monthly releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=391 Melphalan Injection May 28, 2019 Reasons for the Shortage


Par did not provide a reason for the shortage.

Sagent has melphalan injection on shortage due to manufacturing delays.

Estimated Resupply Dates Par has melphalan 50 mg vials on back order and the company cannot estimate a release date.

Sagent has melphalan 50 mg vials on back order and the company cannot estimate a release date.

Teva has short-dated melphalan 50 mg vials available with an expiration date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=525 Sodium Acetate Injection May 28, 2019 Reasons for the Shortage

American Regent is not currently marketing sodium acetate injection.

Fresenius Kabi has sodium acetate injection available.

Pfizer has sodium acetate injection available.

Estimated Resupply Dates Pfizer has sodium acetate 2 mEq/mL 20 mL vials available in limited supply. The 50 mL and 100 mL

vials are on back order and the company estimates a release date of August 2019.




Vecuronium Bromide Injection April 30, 2019 Reasons for the Shortage

Pfizer has vecuronium on shortage due to manufacturing delays.

Teva has vecuronium on allocation due to increased demand.

Pfizer sold vecuronium injection to Mylan Institutional in December 2013.


Ben Venue has stopped production in its plant in Bedford, Ohio and closed in 2014.

Sun Pharma has vecuronium available.

Sagent is not marketing vecuronium 10 mg and 20 mg vials.

Fresenius Kabi has vecuronium available.

Estimated Resupply Dates Pfizer has vecuronium 10 mg and 20 mg vials on back order and the company estimates a release

date of September 2019 for the 10 mg vials and October 2019 for the 20 mg vials. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=167 Cefoxitin Sodium Injection May 29, 2019 Reasons for the Shortage

Apotex has temporarily discontinued cefoxitin vials.

BBraun has cefoxitin on allocation due to increased demand.

Fresenius Kabi did not provide a reason for the shortage.

Hikma did not provide a reason for the shortage. Hikma is not currently marketing cefoxitin 10 gram vials.

Sagent has cefoxitin on shortage due to increased demand and manufacturing delay.

WG Critical Care did not provide a reason for the shortage.

Estimated Resupply Dates Apotex has temporarily discontinued cefoxitin 1 gram, 2 gram, and 10 gram vials and the company

cannot estimate when product will be available again.

BBraun has cefoxitin 1 gram and 2 gram DUPLEX bags on back order and the company cannot estimate a next release date.

Fresenius Kabi has cefoxitin 1 gram and 2 gram vials on back order and the company estimates a release date of late-June 2019 for the 1 gram vials and mid-June 2019 for the 2 gram vials.

Hikma has cefoxitin 1 gram vials on allocation. The 2 gram vials are on back order and the company estimates a release date in June 2019.

Sagent has cefoxitin 1 gram, 2 gram, and 10 gram vials on back order and the company estimates a release date of June 2019.

WG Critical Care has cefoxitin 1 gram, 2 gram, and 10 gram vials on intermittent back order and the company is releasing supplies as they become available (approximately every two weeks).




Ceftazidime Injection May 29, 2019 Reasons for the Shortage

Pfizer has Tazicef available.

Sagent has ceftazidime injection on shortage due to increased demand and manufacturing delays.

BBraun had ceftazidime on allocation due to increased demand.

Teligent discontinued Fortaz 2 gram vials, 6 gram vials, and both 1 gram/50 mL and 2 gram/50 mL premixes in February 2018. They also discontinued the 1 gram and 2 gram TwistVials in April 2019.

WG Critical Care has ceftazidime available.

Estimated Resupply Dates BBraun has ceftazidime 1 gram and 2 gram premixed bags on allocation

Sagent has ceftazidime 2 gram vials on allocation. The 1 gram vials are available with short expiration dating (December 2019).

Teligent has Fortaz 500 mg vials and 1 gram vials on back order and the company estimates a release date of September 2019. They discontinued the 1 gram and 2 gram TwistVials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=63 Cidofovir Injection May 29, 2019 Reasons for the Shortage

Heritage has cidofovir available.

Mylan Institutional refuses to provide updated availability information.

Estimated Resupply Dates N/A

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=486 Furosemide Injection May 29, 2019 Reasons for the Shortage

American Regent is not actively marketing furosemide injection.

Amneal discontinued furosemide injection.

Baxter has furosemide injection available.

Fresenius Kabi has furosemide injection available.

Heritage did not provide a reason for the shortage.

Pfizer had furosemide injection on shortage due to manufacturing delays and increased demand.

Estimated Resupply Dates Heritage has furosemide 10 mg/mL 2 mL, 4 mL, and 10 mL vials on back order with no estimated

release date.

Pfizer has furosemide 10 mg/mL 4 mL syringes available in limited supply. There are short-dated 10 mL vials available with an expiration date of November 2019. The 2 mL vials are on back order and the company estimates a release date of June 2019.




Hepatitis A Virus Vaccine Inactivated May 29, 2019 Reasons for the Shortage

Merck has Vaqta available.

Merck discontinued Vaqta adult formulation 50 U/1 mL vials in 1 count in January 2019.

GlaxoSmithKline has Havrix available.

GlaxoSmithKline discontinued the Havrix pediatric vials in March 2019. The Havrix adult vials were discontinued in November 2017.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=280 Hydroxocobalamin Injection May 29, 2019 Reasons for the Shortage

Meridian Medical Technologies reports that the shortage was due to manufacturing delays and increased demand.

Estimated Resupply Dates Meridian Medical Technologies has Cyanokit injection 5 gram vials available. Check with your

wholesaler for inventory. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=446 Levetiracetam Immediate-Release Tablets May 29, 2019 Reasons for the Shortage

Accord has levetiracetam immediate-release tablets available.

Aurobindo refuses to provide availability information.

Camber has most presentations available.

Lupin did not provide a reason for the shortage.

Major has levetiracetam immediate-release tablets available.

Mylan refused to provide availability information.

OWP did not provide a reason for the Roweepra shortage.

Torrent did not provide a reason for the shortage.

UCB has Keppra immediate-release tablets available.

Estimated Resupply Dates Alcon has Systane Nighttime ointment and Genteal PM ointment on back order and the

company estimates a release date in mid-May 2019. Allergan has Refresh PM, Lacri-Lube SOP ointment 3.5 gram, and Lacri-Lube SOP ointment 7

gram tubes on back order and the company estimates a release date in late-summer 2019. Major has Lubrifresh PM 3.5 gram tubes on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=533



Mepivacaine Injection May 29, 2019 Reasons for the Shortage

Fresenius Kabi did not provide a reason for the shortage.

Pfizer states the reason for the shortage is manufacturing delays.

Estimated Resupply Dates Pfizer has 2% Carbocaine 20 mL preservative-free vials, 2% Carbocaine 50 mL multiple-dose vials, 1%

Carbocaine 30 mL preservative-free vials, 1% Carbocaine 50 mL multiple-dose vials, and 1.5% Carbocaine 30 mL preservative-free vials on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=331 Methocarbamol Tablets May 29, 2019 Reasons for the Shortage

Bayshore states the shortage is due to increased demand.

Virtus, Hikma, and Endo did not provide a reason for the shortage.

Camber states the shortage is due to an API shortage.

Par discontinued methocarbamol tablets in July 2018.

Solco states the shortage is due to an API shortage.

Estimated Resupply Dates Camber has all methocarbamol tablets available for contracted customers. All presentations are on

allocation for non-contracted customers.

Hikma has methocarbamol 500 mg and 750 mg tablets in 500 count on back order and the company estimates a release date of June 2019. Methocarbamol 500 mg and 750 mg tablets in 100 count are on back order and the company cannot estimate a release date.

Solco has all methocarbamol presentations on allocation.

Virtus has all methocarbamol tablets on back order and the company cannot estimate a release date.

Endo has Robaxin 750 mg tablets in 100 count on back order and the company estimates a release date in July 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=423 Rocuronium Injection May 29, 2019 Reasons for the Shortage

Athenex has rocuronium available.


Fresenius Kabi has rocuronium available.

Mylan Institutional refused to provide availability information.

Pfizer has rocuronium on shortage due to manufacturing delays.

Sagent has rocuronium available.

Sandoz has rocuronium available.

X-Gen has rocuronium available.




AuroMedics has rocuronium 10 mg/mL 5 mL and 10 mL vials on intermittent back order and the company is releasing product as it becomes available.

Pfizer has rocuronium 10 mg/mL 5 mL and 10 mL vials available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=290 Spironolactone Tablets May 29, 2019 Reasons for the Shortage

Amneal and Sun Pharma did not provide a reason for the shortage.

Accord and Cadista has spironolactone tablets available.

Mylan refuses to provide updated availability information.

Par discontinued spironolactone tablets in August 2018.

Pfizer has Aldactone available.

Estimated Resupply Dates Sun Pharma has spironolactone 25 mg tablets in 100 and 1000 count, 50 mg tablets in 60 and 500

count, and 100 mg in 100 count on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=447 Valsartan Tablets May 29, 2019 Reasons for the Shortage

Several drug products containing valsartan were recalled due to an unexpected impurity found in the active pharmaceutical ingredient manufactured by a third party. The impurity is N-nitrosodimethylamine (NDMA) and is classified as a probable human carcinogen. Additional information is available at https://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/ucm613532.htm.

Camber, Major, Solco, and Teva valsartan tablets were affected by the recall. Detailed information on the products is available at: https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

Major, Solco, and Teva discontinued valsartan tablets in July 2018.

Alembic, Aurobindo, Cadista, Macleods, and Novartis are not affected by this recall.

Aurobindo and Mylan refuse to provide updated availability information.

Lupin is not actively marketing valsartan tablets.

Repackagers may have some presentations affected depending on the source supplier.

Estimated Resupply Dates Alembic has all 500 count presentations on back order and the company cannot estimate a release

date.

Camber has valsartan tablets on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=444 0.9% Sodium Chloride 10 mL, 20 mL, and 50 mL Preservative Free Vials and Syringes May 30, 2019 Reasons for the Shortage

Fresenius Kabi has recalled multiple lots of 0.9% sodium chloride 10 mL and 20 mL vials due to labels incorrectly stating the stoppers are latex-free. The letter and the lot numbers affected can be found at https://www.fresenius-kabi.com/us/news/fresenius-kabi-issues-voluntary-nationwide-recall-of-sodium.



Pfizer has 0.9% sodium chloride preservative-free vials on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has 0.9% sodium chloride preservative free 20 mL vials available in limited supply. The 50 mL vials are on back order and the company estimates a release date of June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=332 Cefazolin Injection May 30, 2019 Reasons for the Shortage

Apotex has discontinued all presentations except cefazolin 1 gram vials.

Baxter has cefazolin on shortage due to increased demand.

BBraun has cefazolin on shortage due to manufacturing delays.

Fresenius Kabi has cefazolin on shortage due to increased demand. They are not manufacturing the 20 gram vials at this time to focus on the other sizes.


Pfizer states the reason for the shortage is manufacturing delay.

Sagent states the reason for the shortage is manufacturing delays and increased demand.

Samson Medical Technologies has cefazolin injection available.

Sandoz has cefazolin injection available.

WG Critical Care did not provide a reason for the shortage.


Baxter has cefazolin 2 gram/100 mL premixed bags on allocation.

BBraun has 1 gram/50 mL and 2 gram/50 mL premixed bags on allocation.

Fresenius Kabi has cefazolin 500 mg vials and 1 gram vials on back order and the company estimates a release date of late-July to early-August 2019 for the 500 mg vials and mid-June 2019 for the 1 gram vials. The 10 gram vials are on back order and the company estimates a release date of 4th quarter 2019.

Hikma has cefazolin 500 mg, 1 gram, and 10 gram vials on allocation.

Pfizer has 1 gram and 10 gram vials on back order and the company estimates a release date of March 2021. The 1 gram ADD-Vantage vials are available in limited supply.

Sagent has cefazolin 500 mg, 1 gram, and 10 gram vials on intermittent back order and the company will release product on a monthly basis.

WG Critical Care has cefazolin 500 mg vials on back order and the company cannot estimate a release date. The 10 gram vials are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=432 Cefepime Injection May 30, 2019 Reasons for the Shortage

Apotex has cefepime injection available.

Baxter has cefepime on allocation due to increased demand.

BBraun has cefepime on shortage due to manufacturing delays.

Fresenius Kabi has cefepime injection available.

Pfizer has Maxipime on shortage due to manufacturing delays. Sagent has cefepime injection on shortage due to increased demand.

Samson Medical Technologies has cefepime injection available.



Sandoz discontinued cefepime injection in early-2016.

WG Critical Care has cefepime injection available.


Baxter has cefepime 2 gram premixed bags on allocation.

BBraun has cefepime 1 gram and 2 gram premixed bags on allocation.

Pfizer has Maxipime 1 gram and 2 gram vials and 1 gram and 2 gram ADD-Vantage vials on back order and the company estimates a release date of August 2020.

Sagent has cefepime 2 gram vials on back order and the company estimates a release date of June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=59 Ciprofloxacin Injection May 30, 2019 Reasons for the Shortage

Pfizer has ciprofloxacin injection on shortage due to manufacturing delays.

Baxter has ciprofloxacin injection available.


All marketed presentations are available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=396 Dexmedetomidine Hydrochloride 4 mcg/mL Premix for Injection May 30, 2019 Reasons for the Shortage

Pfizer did not provide a reason for the shortage.

WG Critical Care began marketing premixed bags in November 2018.

Baxter has dexmedetomidine premixed bags available.


Pfizer has Precedex 4 mcg/mL 100 mL premixed bottles available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=398 Haloperidol Tablets May 30, 2019 Reasons for the Shortage


Sandoz has discontinued all haloperidol tablet presentations.


Zydus has all haloperidol tablet presentations on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=459 Heparin Sodium Premixed Bags May 30, 2019 Reasons for the Shortage

Baxter has heparin premix available.

BBraun has heparin premixes available.



Fresenius Kabi has heparin premixes available.

Pfizer has heparin on shortage due to manufacturing delays.


Pfizer has heparin 2,000 units/1,000 mL 0.9% sodium chloride premixed bags on back order and the company estimates a release date of June 2019. The 25,000 units/250 mL 0.45% sodium chloride premixed bags are on back order and the company estimates a release date of June 2019. The 25,000 units/250 mL 5% dextrose premixed bags are on back order and the company estimates a release date of June 2019. Heparin 1,000 units/500 mL 0.9% sodium chloride premixed bags are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=468 Morphine Injection May 30, 2019 Reasons for the Shortage

Fresenius Kabi procured morphine syringes from BD in 2016. They discontinued the 8 mg/mL and 10 mg/mL 1 mL syringes in early-2018.

Astramorph injection has been unavailable since 2012. Fresenius Kabi changed manufacturing sites and cannot estimate if Astramorph will return.

Pfizer has a shortage of several prefilled syringe products, including morphine, starting in late-July 2017 due to issues at a manufacturing facility. To minimize the impact of the shortage, Pfizer is prioritizing production of certain morphine Carpuject syringes.


Piramal Critical Care has Mitigo 10 mg/mL 20 mL and 25 mg/mL 20 mL vials available.


Fresenius Kabi has morphine 4 mg/mL 1 mL syringes and 5 mg/mL 1 mL syringes on back order and the company estimates a release date of mid-July 2019. The 8 mg/mL 1 mL vials are on back order and the company estimates a release date of late-June 2019. Check wholesalers for inventory.

Pfizer has morphine 2 mg/mL 1 mL Carpuject syringes available in limited supply. The 0.5 mg/mL 10 mL preservative-free vials are on back order and the company estimates a release date of August 2019. The 1 mg/mL 10 mL preservative-free vials are on back order and the company estimates a release date of August 2019. The 2 mg/mL 1 mL iSecure syringes, 4 mg/mL 1 mL iSecure syringes, 8 mg/mL 1 mL iSecure syringes, and 10 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of September 2019. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of June 2019. The 8 mg/mL 1 mL Carpuject syringes and 10 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of February 2020. The 25 mg/mL 1 mL preservative-free vials are on back order and the company estimates a release date of March 2020. The 50 mg/mL 20 mL vials are on back order and the company estimates a release date of August 2019. The 50 mg/mL 50 mL vials are on back order and the company estimates a release date of August 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=41 Nitrofurantoin Oral Suspension May 30, 2019 Reasons for the Shortage

Amneal did not provide a reason for the shortage.

Casper Pharma did not provide a reason for the Furadantin shortage.

Lupin is no longer manufacturing this product.



Nostrum has nitrofurantoin oral suspension available.

Teva did not provide a reason for the shortage.


Amneal has nitrofurantoin oral suspension on back order and the company cannot estimate a release date.

Casper has Furadantin oral suspension on back order and the company cannot estimate a release date.

Teva has nitrofurantoin oral suspension on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=433 Pantoprazole Injection May 30, 2019 Reasons for the Shortage



Pfizer has Protonix injection on shortage due to manufacturing delays.

Estimated Resupply Dates AuroMedics has pantoprazole 40 mg vials on intermittent back order and the company is releasing

product as it becomes available.

Hikma has pantoprazole 40 mg vials on allocation.

Pfizer has Protonix 40 mg vials in 10 count available in limited supply. There are short-dated 40 mg vials in 25 count available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=550 Sterile Water for Injection - Small Volume Vials May 30, 2019 Reasons for the Shortage

American Regent has sterile water for injection available.

Fresenius Kabi had sterile water on shortage due to increased demand.

Hikma has sterile water for injection available.

Pfizer has sterile water for injection in vials on shortage due to increased demand.


Pfizer has sterile water for injection 100 mL vials on back order and the company estimates a release date of June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=375 Hydromorphone Hydrochloride Injection May 31, 2019 Reasons for the Shortage

Akorn has hydromorphone injection on shortage due to increased demand.

Fresenius Kabi has Dilaudid syringes on shortage due to increased demand. They are focusing their product on the 0.5 mg strength. They launched hydromorphone vials in late-June 2018.


Purdue discontinued Dilaudid and Dilaudid HP in May 2017 for marketing reasons.




Hikma did not provide a reason for the shortage. Estimated Resupply Dates

Fresenius Kabi has Dilaudid 2 mg/mL 1 mL syringes on back order and the company cannot estimate a release date. The hydromorphone 10 mg/mL 1 mL vials are on back order and the company estimates a release date of early-July 2019. The hydromorphone 10 mg/mL 50 mL vials are on back order and the company estimates a release date of late-July to early-August 2019. Check wholesalers for inventory.

Pfizer has 2 mg/mL 1 mL vials available in limited supply. The 10 mg/mL 50 mL vials are on back order and the company estimates a release date of July 2019. The 10 mg/mL 5 mL vials are on back order and the company estimates a release date of June 2019. The 0.5 mg/0.5 mL iSecure syringes are on back order and the company estimates a release date of June 2019. The 1 mg/mL 1 mL ampules, 2 mg/mL 1 mL ampules, and 4 mg/mL 1 mL ampules are on back order and the company estimates a release date of August 2019 for the 1 mL ampules, April 2020 for the 2 mL ampules, and November 2019 for the 4 mL ampules. The 1 mg/mL 1 mL Carpuject syringes are available in limited supply. The 1 mg/mL 1 mL iSecure syringes and 2 mg/mL 1 mL iSecure syringes are on back order and the company estimates a release date of September 2019. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of December 2019.

Teva has 10 mg/mL 1 mL, 5 mL, and 50 mL vials on intermittent back order and the company is allocating upon release.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=329 Metoclopramide Injection May 31, 2019 Reasons for the Shortage

Pfizer has metoclopramide injection on shortage due to manufacturing delays.

Teva had metoclopramide injection on shortage due to increased demand.

Fresenius Kabi had metoclopramide injection on shortage due to increased demand.


Pfizer has metoclopramide 5 mg/mL 2 mL vials on back order and the company estimates a release date of June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=338 Ropivacaine Injection May 31, 2019 Reasons for the Shortage

Akorn has ropivacaine on shortage due to increased demand.


Fresenius Kabi has Naropin on shortage due to increased demand and manufacturing delays.

Pfizer had ropivacaine on shortage due to manufacturing delays.


Akorn has ropivacaine 5 mg/mL 30 mL vials on back order and the company cannot estimate a release date.

AuroMedics has ropivcaine 7.5 mg/mL 20 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has Naropin 5 mg/mL 30 mL Steripak ampules on back order and the company estimates a release date of early-July 2019. The 5 mg/mL 20 mL vials are on back order and the



company estimates a release date of early- to mid-July 2019. The 2 mg/mL 10 mL Steripak ampules are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has ropivacaine 2 mg/mL 10 mL and 20 mL vials on back order and the company estimates a release date of September 2019. The 5 mg/mL 30 mL vials are on back order and the company estimates a release date of August 2019. The 7.5 mg/mL 20 mL vials are on back order and the company estimates a release date of October 2019. The 10 mg/mL 10 mL and 20 mL vials are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=384 Dicyclomine Injection June 3, 2019 Reasons for the Shortage

Allergan has Bentyl injection available.

American Regent did not provide a reason for the shortage.


Nexus has dicyclomine injection for intramuscular use available.


Hikma has dicyclomine 10 mg/mL 2 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=520 Epinephrine Auto-Injectors June 3, 2019 Reasons for the Shortage

Amneal has discontinued Adrenaclick. Amneal acquired Impax in 2018.


Sandoz launched Symjepi in January 2019 and product is available.

Teva has FDA approval for generic epinephrine. Estimated Resupply Dates

Amneal has epinephrine 0.15 mg/0.15 mL and 0.3 mg/0.3 mL auto-injectors on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=420 Epinephrine Injection June 3, 2019 Reasons for the Shortage

Amphastar stopped distributing epinephrine 1 mg/mL 30 mL vials on May 10, 2017. They are continuing to supply 0.1 mg/mL 10 mL syringes. These are on shortage due to increased demand.

Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017.

BPI has epinephrine 1 mg/mL 2 mL ampules available.

Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.


Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation.[1]

Pfizer has epinephrine 0.1 mg/mL 10 mL syringes on back order and the company estimates a release date of August 2019.[2]



Snap Medical Industries has the Epinephrine Snap-V Kit available. Each kit contains an epinephrine 1 mg/mL 1 mL vial, (3) 1 mL luer lock syringes, and (3) 23-gauge 1-inch needles.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=313 Erythromycin Ophthalmic Ointment June 3, 2019 Reasons for the Shortage

Akorn did not provide a reason for the shortage.

Bausch Health did not provide a reason for the shortage.

Perrigo has erythromycin ophthalmic ointment on shortage due to increased demand.


Akorn has erythromycin 0.5% ophthalmic ointment in 3.5 gram tubes on back order and the company is allocating product when it becomes available. The 1 gram tubes are on allocation.

Bausch Health has erythromycin 0.5% ophthalmic ointment in 1 gram and 3.5 gram tubes on back order and the company estimates a release date of mid-June 2019.

Perrigo has erythromycin 0.5% ophthalmic ointment in 1 gram tubes in 50 count and 3.5 gram tubes in 24 count on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=540 Lorazepam Injection June 3, 2019 Reasons for the Shortage

Bedford discontinued lorazepam injection in May, 2011.

Hikma has product on shortage due to manufacturing delays.

Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer discontinued 4 mg/mL 10 mL vials in December 2017.

Akorn has not provided a reason for the shortage.

Amphastar has product available.


Hikma has lorazepam 2 mg/mL 1 mL vials on allocation.

Hikma has Ativan 2 mg/mL 1 mL vials on back order and the company estimates a release date of June 2019.

Pfizer has lorazepam 2 mg/mL 1 mL Carpuject syringes available in limited supply. The 2 mg/mL 1 mL vials are on intermittent back order and the company is releasing product as it becomes available. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of June 2019. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=87 Magnesium Sulfate Injection June 3, 2019 Reasons for the Shortage

American Regent is not currently marketing magnesium sulfate which has been unavailable since late 2012.

Fresenius Kabi had magnesium sulfate injection on shortage due to increased demand for the product.



Pfizer has magnesium sulfate injection on shortage due to manufacturing delays.

X-Gen discontinued magnesium sulfate in April 2018.

Exela launched magnesium sulfate vials in May 2018.

WG Critical Care had magnesium sulfate injection on shortage due to increased demand for the product.


Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of December 2019. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21 Mitoxantrone Hydrochloride Injection June 3, 2019 Reasons for the Shortage

Fresenius Kabi has mitoxantrone available.

Pfizer had mitoxantrone injection on shortage due to manufacturing delays.

Teva has mitoxantrone injection available except for the 10 mL vials which are temporarily discontinued.


Pfizer has mitoxantrone 2 mg/mL 12.5 mL vials on back order and the company estimates a release date of July 2019. There are limited supplies of short-dated 12.5 mL vials with an expiration date of August 2019.

Teva has temporarily discontinued mitoxantrone 10 mL vials and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=414 Epinephrine Injection June 3, 2019 Reasons for the Shortage

Amphastar stopped distributing epinephrine 1 mg/mL 30 mL vials on May 10, 2017. They are continuing to supply 0.1 mg/mL 10 mL syringes. These are on shortage due to increased demand.

Pfizer stopped distributing epinephrine 1 mg/mL presentations on May 10, 2017. BPI has epinephrine 1 mg/mL 2 mL ampules available. Par has Adrenalin 1 mg/mL 1 mL and 30 mL vials available.


Amphastar has epinephrine 0.1 mg/mL 10 mL syringes on allocation. Pfizer has epinephrine 0.1 mg/mL 10 mL syringes on back order and the company estimates a

release date of August 2019. Snap Medical Industries has the Epinephrine Snap-V Kit available. Each kit contains an

epinephrine 1 mg/mL 1 mL vial, (3) 1 mL luer lock syringes, and (3) 23-gauge 1-inch needles. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=313



Erythromycin Ophthalmic Ointment June 3, 2019 Reasons for the Shortage

Akorn did not provide a reason for the shortage. Bausch Health did not provide a reason for the shortage. Perrigo has erythromycin ophthalmic ointment on shortage due to increased demand.


Akorn has erythromycin 0.5% ophthalmic ointment in 3.5 gram tubes on back order and the company is allocating product when it becomes available. The 1 gram tubes are on allocation.

Bausch Health has erythromycin 0.5% ophthalmic ointment in 1 gram and 3.5 gram tubes on back order and the company estimates a release date of mid-June 2019.

Perrigo has erythromycin 0.5% ophthalmic ointment in 1 gram tubes in 50 count and 3.5 gram tubes in 24 count on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=540 Lorazepam injection June 3, 2019 Reasons for the Shortage

Bedford discontinued lorazepam injection in May, 2011. Hikma has product on shortage due to manufacturing delays. Pfizer has product on shortage due to increased demand and manufacturing delays. Pfizer

discontinued 4 mg/mL 10 mL vials in December 2017. Akorn has not provided a reason for the shortage. Amphastar has product available.


Hikma has lorazepam 2 mg/mL 1 mL vials on allocation. Hikma has Ativan 2 mg/mL 1 mL vials on back order and the company estimates a release date

of June 2019. Pfizer has lorazepam 2 mg/mL 1 mL Carpuject syringes available in limited supply. The 2 mg/mL

1 mL vials are on intermittent back order and the company is releasing product as it becomes available. The 4 mg/mL 1 mL vials are on back order and the company estimates a release date of June 2019. The 4 mg/mL 1 mL Carpuject syringes are on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=87 Magnesium Sulfate Injection June 3, 2019 Reasons for the Shortage

American Regent is not currently marketing magnesium sulfate which has been unavailable since late 2012.

Fresenius Kabi had magnesium sulfate injection on shortage due to increased demand for the product.

Pfizer has magnesium sulfate injection on shortage due to manufacturing delays. X-Gen discontinued magnesium sulfate in April 2018. Exela launched magnesium sulfate vials in May 2018.



WG Critical Care had magnesium sulfate injection on shortage due to increased demand for the product.


Pfizer has magnesium sulfate 500 mg/mL 20 mL vials on back order and the company estimates a release date of December 2019. The 500 mg/mL 10 mL syringes are on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=21 Mitoxantrone Hydrochloride Injection June 3, 2019 Reasons for the Shortage

Fresenius Kabi has mitoxantrone available. Pfizer had mitoxantrone injection on shortage due to manufacturing delays. Teva has mitoxantrone injection available except for the 10 mL vials which are temporarily

discontinued. Estimated Resupply Dates

Pfizer has mitoxantrone 2 mg/mL 12.5 mL vials on back order and the company estimates a release date of July 2019. There are limited supplies of short-dated 12.5 mL vials with an expiration date of August 2019.

Teva has temporarily discontinued mitoxantrone 10 mL vials and the company cannot estimate a release date.


Valproate Sodium Injection June 3, 2019 Reasons for the Shortage

Abbvie discontinued Depacon in May 2019. Hikma did not provide a reason for the shortage. Fresenius Kabi did not provide a reason for the shortage.


All marketed presentations are available


Aspirin Suppositories June 4, 2019 Reasons for the Shortage

Perrigo did not provide a reason for the shortage. Estimated Resupply Dates

Perrigo has aspirin 300 mg suppositories on back order and the company estimates a release date of late-June 2019.




Tacrolimus Capsules June 4, 2019 Reasons for the Shortage

Accord has tacrolimus on allocation due to raw ingredient shortage. Bionpharma did not provide a reason for the shortage. Lannett has discontinued tacrolimus capsules. Major did not provide a reason for the shortage. Mylan refuses to provide availability information. Sandoz did not provide a reason for the shortage. Astellas has Prograf available.


Accord has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on allocation. Bionpharma has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on back order and the company

cannot estimate a release date. Major has tacrolimus 0.5 mg and 5 mg capsules on back order and the company estimates a

release date of late-June 2019. The 1 mg capsules are on back order and the company cannot estimate a release date.

Sandoz has tacrolimus 5 mg capsules on back order with an estimated release date of early-June 2019.

Strides has short-dated tacrolimus 1 mg capsules available with an expiration date of April 2020. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=567

0.9% Sodium Chloride Small Volume Bags (< 150 mL) June 5, 2019 Reasons for the Shortage

Baxter did not provide a reason for the 0.9% sodium chloride small volume bags shortage. Most presentations are available.

BBraun has 0.9% sodium chloride small volume bags available. BD has 0.9% sodium chloride small volume bags available. Fresenius Kabi has 0.9% sodium chloride small volume bags available. ICU Medical has 0.9% sodium chloride small volume bags available. Pfizer has 0.9% sodium chloride small volume presentations on shortage due to increased

demand. Estimated Resupply Dates

ICU Medical has 0.9% sodium chloride bags readily available except the 0.9% sodium chloride 100 mL VisIV bags are on allocation to current customers only. The 50 mL VisIV bags are available to contracted customers only.

Pfizer has 0.9% sodium chloride 50 mL preservative-free vials on back order and the company estimates a release date of June 2019.


Amino Acid Products June 5, 2019 Reasons for the Shortage

Baxter has all marketed presentations available. Baxter discontinued Premasol 6% in late-2018. BBraun did not provide a reason for the shortage.



ICU Medical has Aminosyn presentations available. ICU Medical discontinued several Aminosyn products in September 2018.


BBraun has Trophamine 10% 500 mL and Plenamine 15% 1,000 mL glass containers on intermittent back order and the company is releasing supplies as they become available.


Ampicillin Sodium and Sulbactam Sodium Injection June 5, 2019 Reasons for the Shortage

Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-Vantage vials.

Sagent has ampicillin sulbactam vials on back order due to manufacturing delays and increased demand.

Sandoz cannot provide a reason for the shortage. WG Critical Care states the shortage is due to increased demand. Mylan Institutional refuses to provide availability information


AuroMedics has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

Fresenius Kabi has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

Hikma has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the company cannot estimate a release date.

Pfizer has Unasyn 1.5 gram, 3 gram, and 15 gram bulk vials are on back order and the company estimates a release date of July 2019. The 3 gram ADD-Vantage vials are on back order and the company estimates a release date of June 2019.

Sandoz has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

Sagent has ampicillin sulbactam 1.5 gram vials and 15 gram bulk vials on back order and the company cannot estimate a release date. The 3 gram vials are on back order and the company estimates a release date of June 2019.

WG Critical Care has ampicillin sulbactam 1.5 gram and 3 gram vials on back order and the company estimates a release date of early-June 2019. The 15 gram bulk vials are on back order and the company estimates a release date of mid-June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 Clindamycin Phosphate Injection June 5, 2019 Reasons for the Shortage

Alvogen did not provide a reason for the shortage. Akorn did not provide a reason for the shortage. Baxter has clindamycin injection available. Fresenius Kabi did not provide a reason for the shortage. Pfizer did not provide a reason for the shortages. Pfizer discontinued Cleocin premixed bags in

2018.



Sagent has clindamycin injection available. Sandoz did not provide a reason for the shortage.


Akorn has all clindamycin in dextrose premixes available with short expiration dating. Alvogen has clindamycin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage vials on long term back

order and the company cannot estimate a release date. Clindamycin 150 mg/mL 2 mL, 4 mL, and 6 mL vials are short-dated with expiration dates of May 2020 for the 2 mL vials, April 2020 for the 4 mL vials, and February 2020 for the 6 mL vials. Clindamycin 150 mg/mL 60 mL vials are on back order and the company cannot estimate a release date.

Fresenius Kabi has short-dated clindamycin 150 mg/mL 2 mL, 4 mL, 6 mL, and 60 mL vials available with an expiration date of <6 months for the 2 mL vials, <8 months for the 4 mL vials, and <5 months for the 6 mL vials, and <8 months for the 60 mL vials.

Pfizer has Cleocin 150 mg/mL 2 mL, 4 mL, and 6 mL ADD-Vantage vials on back order and the company estimates a release date of July 2019 for the 2 mL vials and August 2019 for the 4 mL and 6 mL vials.

Sagent has short-dated clindamycin 150 mg/mL 2 mL vials with an expiration date of November 2019.

Sandoz has clindamycin 300 mg/50 mL in dextrose on back order and the company estimates a release date in mid-June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=97 Cyclosporine Capsules June 5, 2019 Reasons for the Shortage

Apotex has cyclosporine capsules available. Sandoz has discontinued cyclosporine (modified) capsules. Teva did not provide a reason for the shortage.


All marketed presentations are available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=476 Enoxaparin Sodium Injection June 5, 2019 Reasons for the Shortage

Amphastar has enoxaparin available. Apotex launched enoxaparin in early-2019. Fresenius Kabi has enoxaparin available. Sandoz discontinued enoxaparin presentations in mid-2018 due to a supplier issue. Sanofi-Aventis did not provide a reason for the shortage. Teva did not provide a reason for the shortage. Winthrop did not provide a reason for the shortage.


Sanofi-Aventis has all Lovenox prefilled syringes on allocation.



Teva has enoxaparin 150 mg/1 mL and 120 mg/0.8 mL prefilled syringes on allocation. The 100 mg/1 mL prefilled syringes are on back order and the company is allocating product as it becomes available.

Winthrop has all enoxaparin prefilled syringes on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=466

Etomidate Injection June 5, 2019 Reasons for the Shortage

American Regent is not currently marketing etomidate. Athenex did not provide a reason for the current shortage. AuroMedics did not provide a reason for the current shortage. Hikma has etomidate available. Mylan Institutional refuses to provide updated availability information. Par Sterile Products discontinued etomidate in early 2015. Pfizer has Amidate on shortage due to manufacturing delays. Pfizer discontinued etomidate

ampules in October 2016. Sagent is no longer marketing etomidate. Zydus did not provide a reason for the shortage.


Athenex has etomidate 2 mg/mL 10 mL and 20 mL vials on back order and the company cannot estimate a release date.

AuroMedics has etomidate 2 mg/mL 10 mL and 20 mL vials on intermittent back order and the company is releasing product as it becomes available.

Hikma has etomidate 2 mg/mL 10 ml vials available with short expiration dating (November 2019).

Pfizer has Amidate 2 mg/mL 10 mL vials on back order and the company estimates a release date of August 2019. The 2 mg/mL 20 mL LifeShield syringes on back order and the company estimates a release date of March 2020.

Zydus has etomidate 2 mg/mL 10 mL and 20 mL vials available with short expiration dating. The 10 mL vials have an expiry of March 2020 and the 20 mL vials have an expiry of March 2020 or April 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=147 Fluorescein Sodium Ophthalmic Strips June 5, 2019 Reasons for the Shortage

Hub had Bio-Glo on shortage because demand exceeds supply. Akorn did not provide a reason for the shortage.


Akorn has Ful-Glo 0.6 mg and 1 mg strips on back order and the company is allocating product as it becomes available.




Methotrexate Injection June 5, 2019 Reasons for the Shortage

Accord has methotrexate injection on back order due to increased demand. Fresenius Kabi has methotrexate injection available. Mylan Institutional refuses to provide product availability. Pfizer has methotrexate injection available. Teva has methotrexate injection available. Hikma has methotrexate injection available.


Accord has methotrexate 25 mg/mL 40 mL preservative-free vials on back order and the company estimates a release date of early-June 2019.

Teva has methotrexate 25 mg/mL 40 mL preservative-free vials on allocation. Check availability with wholesalers.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=282 Mycophenolate Mofetil Capsules and Tablets June 5, 2019 Reasons for the Shortage

Accord did not provide a reason for the shortage. Ascend did not provide a reason for the shortage. Hikma did not provide a reason for the shortage. Mylan refuses to provide updated availability information. Genentech has Cellcept available. Sandoz did not provide a reason for the shortage.


Accord has all mycophenolate mofetil presentations on back order and the company cannot estimate a release date.

Ascend has all mycophenolate mofetil presentations on intermittent back order and the company is releasing product as it becomes available.

Hikma has mycophenolate mofetil 250 mg capsules in 100 count and 500 count and 500 mg tablets in 100 count and 500 count on allocation.

Sandoz has mycophenolate mofetil 250 mg capsules in 1440 count are on back order and the company estimates a release date in September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=448 Nelfinavir Mesylate Tablets June 5, 2019 Reasons for the Shortage

Viiv Healthcare states the shortage was due to a manufacturing issue. Viiv Healthcare is the sole supplier of nelfinavir.


N/A https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=543



Norepinephrine Bitartrate Injection June 5, 2019 Reasons for the Shortage

Baxter has norepinephrine injection available. Mylan Institutional refuses to provide product availability. Pfizer has Levophed on shortage due to manufacturing delays. Teva had norepinephrine injection on allocation due to increased demand.


Pfizer has Levophed 1 mg/mL 4 mL ampules on back order and the company estimates a release date of March 2020. The 4 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=292 Sodium Bicarbonate Injection June 5, 2019 Reasons for the Shortage

Amphastar has sodium bicarbonate injection on shortage due to increased demand. Pfizer has sodium bicarbonate injection on shortage due to manufacturing delays. Fresenius Kabi had sodium bicarbonate injection temporarily available, but have run out of

stock, there is more in production at this time. Estimated Resupply Dates

Amphastar has 8.4% sodium bicarbonate 50 mL syringes on allocation. Fresenius Kabi has 8.4% sodium bicarbonate 50 mL vials on back order and the company

estimates a release date of mid-June 2019. Pfizer has 4.2% sodium bicarbonate 10 mL LifeShield syringes, 7.5% sodium bicarbonate 50 mL

syringes, 8.4% 50 mL LifeShield syringes, 8.4% sodium bicarbonate 10 mL syringes, and 8.4% sodium bicarbonate 50 mL vials available in limited supply.

Pfizer has Neut 4% 5 mL vials on back order and the company estimates a release date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=293 Sufentanil Injection June 5, 2019 Reasons for the Shortage

Akorn had Sufenta injection on shortage due to increased demand for the product. Hikma stopped marketing sufentanil injection in October 2018. Pfizer has sufentanil injection on shortage due to manufacturing delays.


Pfizer has sufentanil 0.5 mg/mL 2 mL vials on back order and the company estimates a release date of August 2019.




Temazepam Capsules June 5, 2019 Reasons for the Shortage

Ascend did not provide a reason for the shortage. Major has temazepam on shortage due to manufacturing delays. Mylan refuses to provide availability information. Sun Pharma has temazepam available. Teva did not provide a reason for the shortage. Mallinckrodt has Restoril capsules available.


Ascend has temazepam 15 mg capsules in 100 count on allocation. The 7.5 mg capsules in 100 count and 30 mg capsules in 500 count are on back order and the company cannot estimate a release date.

Major has temazepam 7.5 mg capsules in 100 count bottles on back order and the company cannot estimate a release date


Busulfan Injection June 6, 2019 Reasons for the Shortage

American Regent did not provide a reason for the shortage. Amneal has busulfan injection available. Athenex launched busulfan injection in March 2019. Mylan refuses to provide availability information. Sagent has busulfan injection available. Teva has busulfan injection available. Otsuka has Busulfex available.


American Regent has busulfan 6 mg/mL 10 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=509

Ciprofloxacin Ophthalmic Solution June 6, 2019 Reasons for the Shortage

Akorn did not provide a reason for the shortage. Novartis has Ciloxan available. Sandoz has ciprofloxacin ophthalmic solution available.


Akorn has ciprofloxacin ophthalmic solution on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=443 Dicyclomine Oral Presentations June 6, 2019 Reasons for the Shortage



Hikma did not provide a reason for the shortage. Lannett did not provide a reason for the shortage. Mylan refuses to provide availability information. Par Pharmaceuticals has dicyclomine oral solution available. Teva did not provide a reason for the shortage.


American Regent has busulfan 6 mg/mL 10 mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=509

Busulfan Injection June 6, 2019 Reasons for the Shortage

American Regent did not provide a reason for the shortage. Amneal has busulfan injection available. Athenex launched busulfan injection in March 2019. Mylan refuses to provide availability information. Sagent has busulfan injection available. Teva has busulfan injection available. Otsuka has Busulfex available.


Hikma has 10 mg capsules in 100 and 1,000 count bottles and 20 mg tablets in 100 and 1,000 count bottles available on allocation.

Teva has 10 mg capsules in 100 count and 1,000 count on back order and the company estimates a release date of late-June 2019. The 20 mg tablets in 100 count and 1,000 count bottles are on back order and the company estimates a release date of early-June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=521 Estradiol Valerate Injection June 6, 2019 Reasons for the Shortage

Perrigo did not provide a reason for the shortage. Estimated Resupply Dates

Perrigo has estradiol valerate 40mg/mL 5mL vials available in limited supply. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=570 Labetalol Injection June 6, 2019 Reasons for the Shortage

Akorn did not provide a reason for the shortage. Alvogen did not provide a reason for the shortage. Pfizer has labetalol injection on shortage due to manufacturing delays. Hikma has labetalol injection on shortage due to increase demand.




Akorn has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot estimate a release date.

Alvogen has labetalol 5 mg/mL 20 mL vials on allocation. Hikma has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials are on back order and

the company estimates a release date of July to August 2019. Pfizer has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a

release date of December 2019 for the 20 mL vials and January 2021 for the 40 mL vials. The 5 mg/mL 4 mL Carpuject syringes are on back order and the company estimates a release date of May 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=286 Progesterone Injection June 6, 2019 Reasons for the Shortage

American Regent is not currently marketing progesterone injection. Fresenius Kabi had progesterone on shortage due to increased demand and manufacturing

delays. Hikma did not provide a reason for the shortage. Teva did not provide a reason for the shortage.


Teva has progesterone in oil 50 mg/mL 10 mL vials for intramuscular injection on back order and

the company estimates a release date of mid-June 2019.


Labetalol Injection June 6, 2019 Reasons for the Shortage

Akorn did not provide a reason for the shortage. Alvogen did not provide a reason for the shortage. Pfizer has labetalol injection on shortage due to manufacturing delays. Hikma has labetalol injection on shortage due to increase demand.


Akorn has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company cannot estimate a release date.

Alvogen has labetalol 5 mg/mL 20 mL vials on allocation. Hikma has labetalol 5 mg/mL 20 mL vials on allocation. The 40 mL vials are on back order and

the company estimates a release date of July to August 2019. Pfizer has labetalol 5 mg/mL 20 mL and 40 mL vials on back order and the company estimates a

release date of December 2019 for the 20 mL vials and January 2021 for the 40 mL vials. The 5 mg/mL 4 mL Carpuject syringes are on back order and the company estimates a release date of May 2019.




Sodium Phosphate Injection June 6, 2019 Reasons for the Shortage

American Regent is not currently marketing sodium phosphate injection. Fresenius Kabi states the reason for the shortage was increased demand. Pfizer has sodium phosphate injection on shortage due to manufacturing delay.


Pfizer has sodium phosphate 3 mmol/mL 15 mL vials on back order and the company estimates a release date of March 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=227 Trifluoperazine Tablets June 6, 2019 Reasons for the Shortage

Mylan refuses to provide availability information. Upsher-Smith did not provide a reason for the shortage.


Upsher-Smith and Sandoz have trifluoperazine tablets available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=457 Tropicamide 1% Ophthalmic Solution June 6, 2019 Reasons for the Shortage

Akorn did not provide a reason for the shortage. Alcon has Mydriacyl available. Bausch Health discontinued tropicamide 1% ophthalmic drops in mid-2018. Sandoz did not provide a reason for the shortage.


Sandoz has tropicamide 1% solution in 3 mL bottles available with short expiry of March 2020. Akorn has tropicamide 1% solution in 15 mL bottles on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=547 Clonidine Hydrochloride Injection June 7, 2019 Reasons for the Shortage

American Regent and Fresenius Kabi are not currently marketing clonidine injection. Hikma did not provide a reason for the shortage. Mylan Institutional refuses to provide availability information. X-Gen did not provide a reason for the shortage.


Hikma has clonidine 0.5 mg/mL 10 mL vials on back order and the company estimates a release date of mid-June to early-July 2019.



X-Gen has clonidine 0.5 mg/mL 10 mL vials and 0.1 mg/mL 10 mL vials on intermittent back order with regular releases.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=554 Cosyntropin Injection June 7, 2019 Reasons for the Shortage

Amphastar has Cortrosyn on shortage due to increased demand. Mylan Institutional refuses to provide availability information. Sandoz did not provide a reason for the shortage.


Amphastar and Sandoz have cosyntopin available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=522 Losartan Tablets June 7, 2019 Reasons for the Shortage

Beginning in mid-2018, FDA found that several angiotensin II receptor blocker (ARB) medicines contained nitrosamine impurities and have been recalled because they do not meet FDA's safety standards. Additional information including a list of affected lots can be found at https://www.fda.gov/drugs/drug-safety-and-availability/recalls-angiotensin-ii-receptor-blockers-arbs-including-valsartan-losartan-and-irbesartan.

Camber, Heritage, Teva, and Torrent been affected by the recall. Alembic has losartan tablets available. Aurobindo and Mylan refuse to provide updated availability information. Cadista states the reason for their shortage is issues with obtaining active ingredient. Camber has unaffected lots available to contracted customers. Lupin, Rising, Sandoz, and Zydus did not provide a reason for the shortage. Major has losartan tablets in unit-dose packages available. Merck has Cozaar available. Torrent recalled several lots of losartan tablet presentations due to an impurity found in the

active pharmaceutical ingredient. Additional information can be found at https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/updated-torrent-pharmaceuticals-limited-expands-voluntary-nationwide-recall-losartan-potassium.

Torrent has been unavailable to provide updated availability information. Estimated Resupply Dates

Cadista has losartan potassium tablets on back order and the company cannot estimate a release date.

Camber has 25 mg in 500 count on back order and the company cannot estimate a release date. Heritage has losartan potassium tablets on back order and the company cannot estimate a

release date. Lupin has losartan potassium tablets on back order and the company cannot estimate a release

date. Sandoz has losartan potassium tablets on back order and the company cannot estimate a

release date.



Teva has losartan potassium tablets on back order and the company cannot estimate a release date.

Zydus has losartan potassium tablets on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=572 Secobarbital Capsules June 7, 2019 Reasons for the Shortage

Bausch Health is the sole supplier of secobarbital capsules. The company states that Seconal capsules are on back order due to a short-term stock out.


Bausch Health has Seconal (secobarbital) 100 mg capsules on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=517 Thrombin Topical Solution (Bovine) June 7, 2019 Reasons for the Shortage

Pfizer has Thrombin-JMI on shortage due to manufacturing delays. Recombinant thrombin is not affected by this shortage


Pfizer has Thrombin-JMI 20,000 unit syringe spray kits, 5,000 unit epistaxis kits, 5,000 unit vials, and 5,000 unit syringe spray kits available in limited supply. The 20,000 unit pump spray kits are on back order and the company estimates a release date of August 2019. The 20,000 unit vials are on back order and the company estimates a release date of September 2019.


Amiodarone Injection June 10, 2019 Reasons for the Shortage

Baxter has Nexterone premixed bags on shortage due to manufacturing delays. Mylan Institutional did not provide a reason for the shortage. Hikma did not provide a reason for the shortage; however, the 50 mg/mL, 3 mL 10 count

presentation was discontinued in December 2018. Estimated Resupply Dates

AuroMedics has amiodarone 50 mg/mL 3 mL, 9 mL, and 18 mL vials on intermittent back order and the company is releasing product as it becomes available.

Baxter has Nexterone 150 mg/100mL and 360 mg/200mL premixed bags on allocation. Fresenius Kabi has amiodarone 50 mg/mL 3 mL and 9 mL vials on back order and the company

estimates a release date of mid-June 2019. Hikma has amiodarone 50 mg/mL 3 mL vials on back order and the company estimates a release

date of late-June to early-July 2019. Sagent has amiodarone 50 mg/mL 3 mL vials on back order and the company cannot estimate a

release date. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=374



Bivalirudin Injection June 10, 2019 Reasons for the Shortage

Accord has temporarily discontinued bivalirudin. Apotex has discontinued bivalirudin. AuroMedics did not provide a reason for the shortage. Baxter has bivalirudin premixed bags available. Fresenius Kabi did not provide a reason for the shortage. Pfizer has bivalirudin on shortage due to manufacturing delays. Sandoz did not provide a reason for the shortage.


AuroMedics has bivalirudin 250 mg vials on intermittent back order and the company is releasing product as it becomes available.

Pfizer has bivalirudin 250 mg vials available in limited supply. The 250 mg ADD-Vantage vials are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=569 Bupivacaine Injection June 10, 2019 Reasons for the Shortage

AuroMedics has not provided a reason for the shortage. Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product. Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5%

bupivacaine 30 mL glass ampules in December 2017. Estimated Resupply Dates

AuroMedics has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on intermittent

back order and the company is releasing product as it becomes available. The 0.5% bupivacaine

10 mL and 30 mL preservative-free vials are on intermittent back order and the company is

releasing product as it becomes available. The 0.75% bupivacaine 10 mL and 30 mL preservative-

free vials are on intermittent back order and the company is releasing product as it becomes

available.

Fresenius Kabi has 0.25% Sensorcaine 30 mL preservative-free vials on back order and the

company estimates a release date of mid-June 2019. The 0.25% and 0.5% Sensorcaine 30 mL

preservative-free vials in sterile packs are on back order and the company cannot estimate

release dates.

Pfizer has 0.25% bupivacaine 10 mL preservative-free vials on back order and the company

estimates a release date of August 2019. The 0.25% bupivacaine 30 mL preservative-free vials

are on back order and the company estimates a release date of June 2019. The 0.25%

bupivacaine 50 mL vials are on back order and the company estimates release dates of August

2019. The 0.5% bupivacaine 10 mL preservative-free vials are on back order and the company

estimates a release date of December 2019. The 0.5% bupivacaine 30 mL preservative-free vials

are available in limited supply. The 0.5% bupivacaine 50 mL vials are on back order and the



company estimates a release date of June 2019. The 0.75% bupivacaine 30 mL preservative-free

vials are on back order and the company estimates a release date of August 2019.

Pfizer has 0.25% Marcaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of September 2019 for the 10 mL vials and July 2019 for the 30 mL vials. The 0.25% 50 mL vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of November 2019 for the 10 mL vials and January 2020 for the 30 mL vials. The 0.5% 50 mL vials are on back order and the company estimates a release date of June 2019. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=172 Leucovorin Calcium Injection June 10, 2019 Reasons for the Shortage

Fresenius Kabi had leucovorin on shortage due to manufacturing delays and increased demand. Hikma did not provide a reason for the current shortage. Mylan refuses to provide availability information. Sagent has leucovorin on shortage due to manufacturing delays. Teva has leucovorin available.


Fresenius Kabi has leucovorin 200 mg vials on back order and the company estimates a release date of mid-June 2019.

Hikma has leucovorin 50 mg, 200 mg, and 350 mg vials on back order and the company estimates a release date of late-June to early-July 2019.

Sagent has leucovorin 50 mg, 100 mg, 200 mg, 350 mg, and 500 mg vials on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35 Aminophylline Injection June 11, 2019 Reasons for the Shortage

Pfizer has aminophylline injection on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has aminophylline 25 mg/mL 20 mL vials on back order and the company estimates a release date of September 2019. The 10 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=407 Aminophylline Injection June 11, 2019 Reasons for the Shortage

Pfizer has aminophylline injection on shortage due to manufacturing delays. Estimated Resupply Dates

Pfizer has aminophylline 25 mg/mL 20 mL vials on back order and the company estimates a release date of September 2019. The 10 mL vials are available in limited supply.



https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=407 Amyl Nitrite Inhalation June 11, 2019 Reasons for the Shortage

James Alexander has amyl nitrite inhalation on shortage because they are in the process of serializing the product.


James Alexander has amyl nitrite inhalation on back order and the company estimates a release date in early- to mid-July 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=505 Asparaginase Erwinia chrysanthemi June 11, 2019 Reasons for the Shortage

Jazz Pharmaceuticals did not provide a reason for the shortage. Estimated Resupply Dates

Jazz Pharmaceuticals has Erwinaze 10,000 unit vials in 1 count and 5 count on back order and the company cannot estimate a release date. There is a new process for ordering Erwinaze. Additional information regarding the new ordering process is available at www.erwinazesupply.com.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=482 Buspirone Tablets June 11, 2019 Reasons for the Shortage

Accord did not provide a reason for the shortage. Mylan refuses to provide updated availability information. Par has buspirone tablets available. Teva did not provide a reason for the shortage.


Accord has all buspirone presentations on back order and the company cannot estimate a release date.

Teva has buspirone 5 mg tablets in 500 count bottles, 10 mg tablets in 500 count bottles, 15 mg in 100 and 500 count bottles, and 30 mg tablets in 60 and 500 count bottles on intermittent back order and the company is releasing supplies as they become available. The 10 mg tablets in 100 count bottles are on back order with an estimated release date in early-August 2019.

Zydus has all buspirone presentations on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=465 Daptomycin Injection June 11, 2019 Reasons for the Shortage

Fresenius Kabi has daptomycin available. Mylan Institutional refuses to provide availability information.



Pfizer has daptomycin on shortage due to manufacturing delays. Teva has daptomycin available. Sagent has daptomycin on shortage due to manufacturing delays. Merck has Cubicin and Cubicin RF available. Xellia Pharmaceuticals has daptomycin available.


Pfizer has daptomycin 500 mg vials on back order and the company estimates a release date of March 2020.

Sagent has daptomycin in 1 count and 10 count on back order and the company estimates a release date of June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=467 Heparin Injection June 11, 2019 Reasons for the Shortage

Fresenius Kabi has heparin on shortage due to increased demand. Hikma did not provide a reason for the shortage. Mylan refuses to provide updated availability information. Pfizer did not provide a reason for the shortage. Sagent has heparin on shortage due to manufacturing issues and increased demand.


Fresenius Kabi has heparin 1,000 unit/mL 2 mL vials on back order and the company estimates a release date of mid-July 2019. The 10,000 unit/mL 4 mL vials are on back order and the company cannot estimate a release date. The 20,000 unit/mL 1 mL vials have short expiration dating (< 9 months).

Hikma has 1,000 unit/mL 30 mL vials and 5,000 unit/mL 10 mL vials on back order and the company cannot estimate a release date. The 1,000 unit/mL 2 mL vials are on back order and the company estimates a release date of late-June to early-July 2019. The 5,000 unit/mL 2 mL vials and 10,000 unit/mL 2 mL vials are on allocation.

Pfizer has 5,000 unit/mL 1 mL Carpuject syringes on back order and the company estimates a release date in November 2019. The 5,000 unit/mL 1 mL glass vials and 10,000 unit/mL 1 mL glass vials on back order and the company estimates a release date of August 2019. The 1,000 unit/mL 1 mL glass vials and 1,000 unit/mL 10 mL vials are on back order and the company estimates a release date in August 2019. The 10,000 unit/mL 0.5 mL carpuject syringes and 1,000 unit/mL 30 mL glass vials are available in limited supply. The 5,000 unit/mL 10 mL vials are on back order and the company estimates a release date in December 2019.

Sagent has 1,000 unit/mL 1 mL vials, 1,000 unit/mL 2 mL vials, 1,000 unit/mL 10 mL vials, and 20,000 unit/mL 1 mL vials on allocation. The 5,000 unit/mL 1 mL vials, 10,000 unit/mL 1 mL vials, and 10,000 unit/mL 4 mL vials are on back order and the company estimates a release date of June 2019. The 5,000 unit/mL 10 mL vials are on back order and the company estimates a release date in July 2019.




Ketorolac Injection June 11, 2019 Reasons for the Shortage

Alvogen did not provide a reason for the shortage. Amphastar did not provide a reason for the shortage. Athenex has ketorolac available. BD RX is now part of Fresenius Kabi. Fresenius Kabi has most ketorolac presentations available. Fosun Pharma has ketorolac available. Pfizer has ketorolac injection on back order due to manufacturing delays. Sagent states the reason for the shortage is manufacturing delay. Hikma did not provide a reason for the shortage. Ben Venue closed its plant in Bedford, Ohio in July 2014. Virtus discontinued ketorolac in March 2019. FDA imposed an import ban in mid-2013 on several Wockhardt products including ketorolac. Sprix Nasal Spray is not affected by this shortage.


Alvogen has ketorolac 30 mg/mL 1 mL vials and 2 mL vials on back order and the company estimates a release date of late-July 2019 for the 1 mL vials and late-June 2019 for the 2 mL vials.

Amphastar has ketorolac 30 mg/mL 1 mL vials on back order and the company cannot estimate a release date

Fresenius Kabi has ketorolac 15 mg/mL 1 mL prefilled syringes on back order and the company estimates a release date of 3rd quarter 2019. The 30 mg/mL 2 mL syringes for intramuscular use are on back order and the company estimates a release date of 3rd quarter 2019. Product is available with short expiration dating for ketorolac 15 mg/mL 1 mL prefilled syringes (< 1 month) and 30 mg/mL 2 mL prefilled syringes for intramuscular use (< 2 months). The 30 mg/mL 1 mL vials are on back order and the company estimates a release date of mid- to late-June 2019. There are short-dated 30 mg/mL 1 mL syringes available with an expiration date of <9 months.

Hikma has all ketorolac presentations on back order. The company estimates a release date of June 2019 for the ketorolac 15 mg/mL 1 mL vials. The company estimates a release date of July 2019 for the 30 mg/mL 1 mL and 2 mL vials.

Pfizer has ketorolac 30 mg/mL 1 mL Carpuject syringes, 30 mg/mL 2 mL Carpuject syringes for intramuscular injection, and 30 mg/mL 1 mL iSecure syringes on back order and the company estimates a release date of March 2020 for the 1 mL and 2 mL Carpuject syringes and September 2019 for the 1 mL iSecure syringes. The ketorolac 30 mg/mL 1 mL vials are on back order and the company estimates a release date of August 2019.

Sagent has ketorolac 15 mg/mL 1 mL vials, 30 mg/mL 1 mL vials, and 30 mg/mL 2 mL vials for intramuscular injection are on back order and the company estimates a release date of June 2019.




Latanoprost Ophthalmic Solution June 11, 2019 Reasons for the Shortage

Akorn has discontinued latanoprost ophthalmic solution. Bausch Health has latanoprost ophthalmic solution available. Greenstone did not provide a reason for the shortage of latanoprost ophthalmic solution. Rising did not provide a reason for the shortage. Sandoz (Falcon) has latanoprost ophthalmic solution available.


Greenstone has latanoprost ophthalmic solution on back order and the company cannot estimate a release date.

Rising has latanoprost ophthalmic solution on allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=507 Levetiracetam Injection June 11, 2019 Reasons for the Shortage

American Regent did not provide a reason for the shortage. Athenex has product available. AuroMedics did not provide a reason for the shortage. Fresenius Kabi has product available. Mylan refuses to provide updated availability information. Pfizer has product available. Sagent has product available. Sun Pharma did not provide a reason for the shortage. UCB has product available. Hikma has product available. X-Gen has product available.


AuroMedics has levetiracetam 5 mg/mL 100 mL, 10 mg/mL 100 mL, and 15 mg/mL 100 mL premixed bags on back order and the company cannot estimate a release date.

Hikma has levetiracetam 100 mg/mL 5 mL vials on back order and the company estimates a release date in late-June to early-July 2019.

Sun Pharma has levetiracetam 100 mg/mL 5 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=84 Scopolamine Transdermal System June 11, 2019 Reasons for the Shortage

Baxter has scopolamine patches available.

GlaxoSmithKline states the shortage was due to increased demand.

Perrigo did not provide a reason for the shortage.


Perrigo has scopolamine patches on back order and the company cannot estimate a release date.



https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=442 Sterile Talc June 11, 2019 Reasons for the Shortage

Lymol has Sclerosol and talc powder on shortage due to manufacturing delays. Novatech SA has Steritalc available.


Lymol has Sclerosol and talc powder on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=260 Vancomycin Hydrochloride Injection June 11, 2019 Reasons for the Shortage

Alvogen has vancomycin injection available.

Athenex has vancomycin injection available.


Pfizer has vancomycin vials on back order due to manufacturing delays.

Fresenius Kabi has vancomycin injection available.


Baxter has vancomycin injection available.

Samson Medical Technologies has vancomycin injection available.

Sagent has vancomycin injection available.

Xellia Pharmaceuticals has vancomycin injection and vancomycin premixed bags available. Estimated Resupply Dates

Athenex has vancomycin 500 mg vials on back order and the company estimates a release date of late-June 2019.

AuroMedics has vancomycin 1 gram vials on long-term back order and the company cannot estimate a release date.

Fresenius Kabi has vancomycin 750 mg vials on back order and the company estimates a release date of late-June 2019.

Pfizer has 500 mg ADD-Vantage vials and 750 mg vials available in limited supply. The 500 mg vials are on back order and the company estimates a release date of June 2019. There are short-dated 500 mg vials available. The 750 mg ADD-Vantage vials are on back order and the company estimates a release date of March 2020. The 1 gram ADD-Vantage vials are on back order and the company estimates a release date of June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=25 Letermovir Injection June 12, 2019 Reasons for the Shortage

Merck has Prevymis on shortage due to a supply disruption. Estimated Resupply Dates



Merck has Prevymis 20 mg/mL 12 mL and 24 mL vials on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=487 Piperacillin and Tazobactam Injection June 12, 2019 Reasons for the Shortage

Apotex has piperacillin/tazobactam injection available. Athenex has piperacillin/tazobactam injection available. AuroMedics did not provide a reason for the shortage. Baxter has piperacillin/tazobactam injection available. Fresenius Kabi has piperacillin/tazobactam injection available. Mylan Institutional refuses to provide updated availability information. Pfizer has Zosyn single dose vials and piperacillin/tazobactam on shortage due to manufacturing

delays. Sagent has piperacillin/tazobactam injection on shortage due to increased demand. Sandoz has piperacillin/tazobactam injection available. WG Critical Care has piperacillin/tazobactam injection available. Wockhardt has piperacillin/tazobactam injection available. X-Gen has piperacillin/tazobactam injection available.


Auromedics has piperacillin/tazobactam 3.375 gram vials on intermittent back order and the company is releasing supplies as they become available.

Fresenius Kabi has piperacillin/tazobactam 4.5 gram vials on back order and the company estimates a release date in mid- to late-June 2019.

Pfizer has Zosyn 2.25 gram vials, 3.375 gram vials, 4.5 gram vials, and 40.5 gram vials on back order and the company estimates a release date of March 2020. The piperacillin/tazobactam 2.25 gram ADD-Vantage vials are on back order and the company estimates a release date of September 2019.

Sagent has piperacillin/tazobactam 3.375 gram and 4.5 gram vials on back order and the company estimates a release date of June 2019. There are short-dated 2.25 gram vials available with an expiration date of October 2019.


Tuberculin June 12, 2019 Reasons for the Shortage

Par currently has Aplisol available but the company anticipates a supply interruption starting in June 2019.

Sanofi Pasteur has Tubersol available. Estimated Resupply Dates

All marketed products are currently available. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=573



Fludrocortisone Acetate Tablets June 13, 2019 Reasons for the Shortage

Impax did not provide a reason for the shortage. Teva did not provide a reason for the shortage.


Teva has fludrocortisone acetate 0.1 mg tablets temporarily unavailable and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=484 Meropenem Injection June 13, 2019 Reasons for the Shortage

Amneal did not provide a reason for the shortage. AuroMedics did not provide a reason for the shortage. Pfizer has meropenem injection on shortage due to manufacturing delays. Sagent discontinued meropenem injection.


AuroMedics has meropenem 1 gram vials on intermittent back order and the company is shipping product as it becomes available.

Pfizer has Merrem 500 mg vials (NDC 00310-0325-20) and 1 gram vials (NDC 00310-0321-30) on back order and the company estimates a release date of March 2020. Pfizer has generic meropenem 500 mg and 1 gram vials on back order and the company estimates a release date of August 2020.

Sandoz has meropenem 500 mg vials in 10-count packages available with short expiry off late-October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=475 Nicardipine Hydrochloride Injection June 13, 2019 Reasons for the Shortage

Hikma has nicardipine vials available. Mylan refuses to provide availability information. Chiesi did not provide a reason for the shortage.

Estimated Resupply Dates Chiesi has all Cardene IV premixed bags on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=574 Prednisone Oral Tablets June 13, 2019 Reasons for the Shortage

Cadista, Hikma, Par, and Teva did not provide a reason for the shortage. Estimated Resupply Dates

Cadista has prednisone 1 mg, 5 mg, 10 mg, and 20 mg tablet presentations on allocation.



Hikma has prednisone 1 mg in 1,000 count bottles, 5 mg in 100 count unit dose packages, and 20 mg in 500 count bottles on back order and the company estimates a release date in late-June 2019. Several other prednisone tablet presentations are on allocation.

Par has prednisone 10 mg tablets in 500 count bottles on back order and the company estimates a release date of late-June 2019.

Teva has prednisone 5 mg and 10 mg in 21 and 48 count unit dose packages on back order and the company estimates a release date in early-July 2019. Prednisone 10 mg in 500 count bottles and 20 mg in 1,000 count bottles are on back order and the company estimates a release date of mid-June 2019. Prednisone 10 mg in 1,000 count bottles are on back order and the company estimates a release date of late-June 2019. The 20 mg in 100 count and 500 count bottles are on back order and the company estimates a release date in late-June 2019 for the 100 count bottles and mid- to late-July 2019 for the 500 count bottles.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=574 Diclofenac Potassium Tablets June 14, 2019 Reasons for the Shortage



Sandoz discontinued diclofenac potassium tablets. Estimated Resupply Dates

Teva has diclofenac potassium 50 mg tablets in 100 count and 500 count on back order and the company estimates a release date of late-August 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=537 Indomethacin Capsules June 14, 2019 Reasons for the Shortage

Alvogen has metoprolol injection available.[1]

American Regent is not currently marketing metoprolol injection.[2]

Athenex has metoprolol injection available.

Baxter has metoprolol injection available.

Fosun Pharma has metoprolol injection available.

Fresenius Kabi had metoprolol injection on shortage due to increased demand.

Mylan Institutional acquired metoprolol injection from Sagent. They discontinued metoprolol injection in March 2018.

Pfizer has metoprolol injection on shortage due to manufacturing delays.


Estimated Resupply Dates Hikma has metoprolol 1 mg/mL 10 mL vials on back order and the company estimates a release date

of late-June to mid-July 2019. The 5 mL vials are on back order and the company cannot estimate a release date.

Pfizer has metoprolol 1 mg/mL 5 mL Carpuject syringes on back order and the company estimates a release date of August 2020. The 1 mg/mL 5 mL ampules are on back order and the company estimates a release date of August 2020. The 1 mg/mL 5 mL vials are on back order and the company estimates a release date of August 2019.




Physostigmine Salicylate Injection June 18, 2019 Reason for the Shortage

Akorn did not provide a reason for the shortage. They are the sole suppliers of physostigmine salicylate injection.

Estimated Resupply Dates Akorn has short-dated physostigmine salicylate 1 mg/mL 2 mL ampules available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=532 14.6% Sodium Chloride Concentrated Solution for Injection June 18, 2019 Reason for the Shortage

Pfizer has 14.6% sodium chloride concentrated solution for injection on shortage due to manufacturing delays.

Estimated Resupply Dates Pfizer has 14.6% sodium chloride concentrated solution for injection 20 mL vials on back order and

the company estimates a release date of March 2020. The 40 mL vials are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=416 23.4% Sodium Chloride Injection June 18, 2019 Reason for the Shortage

Fresenius Kabi has 23.4% sodium chloride injection on shortage due to increased demand.

Pfizer has 23.4% sodium chloride injection on shortage due to increased demand.

Estimated Resupply Dates Fresenius Kabi has 23.4% sodium chloride 100 mL vials on back order and the company estimates a

release date of mid-July 2019. Check wholesalers for inventory.

Pfizer has 23.4% sodium chloride 200 mL vials on back order and the company estimates a release date of December 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=336 BCG Live Intravesical June 18, 2019 Reason for the Shortage

Because of increased global demand, and as the only source of BCG Live (Intravesical) in the United States and many other countries, Merck anticipates supply constraints for Tice BCG in 2019. To minimize disruption to patient care and address the current imbalance between supply and increased global demand, Tice BCG will be under allocation when demand exceeds production plans and available inventory.

Estimated Resupply Dates Merck has Tice BCG on allocation.




Bumetanide Injection June 18, 2019 Reason for the Shortage

Pfizer has bumetanide injection on shortage due to manufacturing delays.

Hikma has bumetanide injection available.

Estimated Resupply Dates Pfizer has bumetanide 0.25 mg/mL 4 mL and 10 mL vials on back order and the company estimates a

release date of December 2019 for the 4 mL vials and March 2020 for the 10 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=307 Bupivacaine with Epinephrine Injection June 18, 2019 Reason for the Shortage

Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and manufacturing delays.

Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays.

Estimated Resupply Dates Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the

company estimates a release date of late-June 2019. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of mid-June 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of mid-June 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date.

Pfizer has 0.25% bupivacaine with epinephrine 30 mL preservative-free vials on back order and the company estimates a release date of December 2019. The 0.25% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of November 2019. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of December 2019. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of February 2020. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2019.The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of December 2019.

Pfizer has 0.25% Marcaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of September 2019. The 0.25% Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of July 2019. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of June 2021. The 0.5% Marcaine with epinephrine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=261 Carbidopa and Levodopa Extended-Release Tablets June 18, 2019 Reason for the Shortage

Accord has discontinued carbidopa and levodopa 25 mg/100 mg extended-release tablets. The 50 mg/200 mg tablets are on shortage due to problems obtaining active ingredient.



Sun Pharma had carbidopa and levodopa extended-release tablets on shortage due to increased demand.

Merck had Sinemet CR on shortage due to increased demand.


Estimated Resupply Dates Accord has carbidopa and levodopa 50 mg/200 mg extended-release tablets on allocation.

Merck has Sinemet CR 25 mg/100 mg extended release tablets in 100 count bottles on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=349 Cefotaxime Sodium Injection June 18, 2019 Reason for the Shortage

Hospira has discontinued Claforan. Sanofi-Aventis manufactured Claforan for Hospira and is no longer making the product.

Baxter discontinued Claforan in late-2015.

Hikma is not currently marketing cefotaxime injection.

Estimated Resupply Dates There are no marketed presentations available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=51 Dexamethasone Sodium Phosphate Injection June 18, 2019 Reason for the Shortage

American Regent is not marketing dexamethasone sodium phosphate injection at this time.

AuroMedics has dexamethasone sodium phosphate on intermittent back order.

Fresenius Kabi has dexamethasone sodium phosphate presentations available.



Estimated Resupply Dates AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL, 5mL, and 30 mL vials on

intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has dexamethasone sodium phosphate 10 mg/mL 1 mL preservative-free vials on back order and the company estimates a release date of late-June 2019. The 4 mg/mL 1 mL and 30 mL vials are on back order and the company estimates a release date of mid-June 2019 for the 1 mL vials and early-July 2019 for the 30 mL vials. The 10 mg/mL 10 mL vials are on back order and the company estimates a release date of late-June 2019.

Hikma has dexamethasone sodium phosphate 4 mg/mL 1 mL vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=140 Dexrazoxane Injection June 18, 2019 Reason for the Shortage

Cumberland Pharmaceuticals relaunched Totect in late-July 2017.

Fosun Pharma has dexrazoxane available.



Pfizer states manufacturing delay as the reason for the shortage.



Estimated Resupply Dates Pfizer has Zinecard 500 mg vials on back order and the company estimates a release date of

December 2019.

Hikma has dexrazoxane 500 mg vials on back order and the company estimates a release date of late-June to mid-July 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=107 Dopamine Hydrochloride Injection June 18, 2019 Reason for the Shortage

American Regent is not marketing dopamine injection.

Baxter had dopamine on shortage due to manufacturing delays.

Pfizer states the shortage is due to manufacturing delays. The dopamine 200 mg/250 mL and 400 mg/500 mL premixed bags were discontinued in August 2017.

Estimated Resupply Dates Pfizer has dopamine 40 mg/mL 5 mL and 10 mL vials on back order and the company estimates a

release date of August 2019 for the 5 mL vials and December 2019 for the 10 mL vials. The 400 mg/250 mL premixed bags are on back order and the company estimates a release date of July 2019. The 800 mg/250 mL premixed bags are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=246 Erythromycin Lactobionate Injection June 18, 2019 Reason for the Shortage

Pfizer has Erythrocin on shortage due to manufacturing delays.

Estimated Resupply Dates Pfizer has Erythrocin 500 mg ADD-Vantage vials on back order and the company estimates a release

date of October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=247 Lidocaine Injection June 18, 2019 Reason for the Shortage

Amphastar had lidocaine 2% emergency syringes on shortage due to increase demand for the product.

AuroMedics introduced lidocaine injection in February 2014.

Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of raw ingredients.

Pfizer has lidocaine presentations on shortage due to manufacturing delays. Estimated Resupply Dates

Amphastar has 2% lidocaine 5 mL syringes on intermittent back order and the company is releasing product as it becomes available.

AuroMedics has 1% lidocaine 5 mL ampules and 5 mL vials on intermittent back order and the company is releasing product as it becomes available. AuroMedics has 2% lidocaine 5 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has lidocaine 2 mL vials on back order and the company estimates a release date of late-July 2019. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the company



cannot estimate a release date. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of 3rd quarter 2019. Check wholesalers for inventory.

Hikma has 2% lidocaine 5 mL vials on back order and the company estimates a release date of July to August 2019.

Pfizer has 1% lidocaine 5 mL preservative-free ampules on back order and the company estimates a release date of March 2020. The 1% lidocaine 20 mL vials are available in limited supply. The 1% lidocaine 30 mL preservative-free vials are on back order and the company estimates a release date of July 2019. The 1% lidocaine 50 mL vials are on back order and the company estimates a release date of August 2019. The 1% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of August 2019. The 1.5% lidocaine 20 mL preservative-free ampules are on back order and the company estimates a release date of September 2019. The 2% lidocaine 10 mL ampules are on back order and the company estimates a release date of August 2019. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of June 2019. The 2% lidocaine 20 mL vials are on back order and the company estimates a release date of August 2019. The 2% lidocaine 50 mL vials are on intermittent back order and the company is releasing product as it becomes available. The 2% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of August 2019. The 2% lidocaine 5 mL Ansyr syringes are on intermittent back order and the company is releasing product as it becomes available. The 4% lidocaine 5 mL ampules are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=247 Lidocaine with Epinephrine Injection June 18, 2019 Reason for the Shortage

Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand for the product and manufacturing delays.

Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays.

Estimated Resupply Dates Fresenius Kabi has 1% Xylocaine with epinephrine (1:200,000) 10 mL vials on back order and the

company estimates release dates of late-June 2019. The 1% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates release dates of mid-June 2019. The 1% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates release dates of late-June 2019. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of early-July 2019. The 2% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates a release date of early- to mid-July 2019. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has 1% lidocaine with epinephrine (1:100,000) 20 mL vials on back order and the company estimates a release date of June 2019. The 1% lidocaine with epinephrine (1:100,000) 30 mL vials are on back order and the company estimates a release date of July 2019. The 1% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of June 2019. The 1.5% lidocaine with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates a release date of July 2019. The 1.5% lidocaine with epinephrine (1:200,000) 5 mL glass ampules are on back order and the company estimates a release date of July 2019. The 2% lidocaine with epinephrine (1:100,000) 20 mL vials are on back order and the company estimates a release date of June 2019. The 2% lidocaine with epinephrine (1:100,000) 30 mL vials are on back



order and the company estimates a release date of July 2019. The 2% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of June 2019.The 2% lidocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=98 Morphine PCA Vials June 18, 2019 Reason for the Shortage

ICU Medical has morphine PCA vials on shortage due to manufacturing delays.

Amphastar's morphine PCA vials are not affected by the shortage.

Estimated Resupply Dates ICU Medical has morphine 1 mg/mL 30 mL PCA vials on allocation to contracted customers. The 5

mg/mL 30 mL PCA vials are on back order and the company estimates a release date of late-September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=436 PCA Sterile Empty Vials and Injector June 18, 2019 Reason for the Shortage

ICU Medical has LifeCare PCA sterile empty vials and injectors on shortage due to manufacturing delays.

ICU Medical has LifeCare PCA sterile empty vials and injectors on allocation to contracted customers.

Estimated Resupply Dates ICU Medical has LifeCare PCA sterile empty vials and injectors on allocation to contracted customers.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=493 Phenytoin Sodium Injection June 18, 2019 Reason for the Shortage

Hikma did not provide a reason for this shortage.

X-Gen Pharmaceuticals discontinued their phenytoin sodium presentations in April 2017.

Estimated Resupply Dates Hikma has phenytoin sodium 50 mg/mL 2 mL and 5 mL vials available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=406 Thiamine Injection June 18, 2019 Reason for the Shortage

Fresenius Kabi has thiamine injection on shortage due to short manufacturing delay.


Estimated Resupply Dates Fresenius Kabi has thiamine 100 mg/mL 2 mL vials on back order and the company estimates a





Tirofiban Hydrochloride Injection June 28, 2019 Reason for the Shortage

Medicure Pharma has Aggrastat on shortage due to an interruption at their third-party manufacturing site.

Estimated Resupply Dates Medicure Pharma has Aggrastat 5 mg/mL 100 mL premixed vials on back order and the company

estimates a release date sometime in 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=571 Verapamil Extended-Release Tablets June 18, 2019 Reason for the Shortage

Glenmark did not provide a reason for the shortage.



Estimated Resupply Dates Glenmark has verapamil 180 mg extended-release tablets in 100 count and 500 count and 240 mg

extended-release tablets in 100 count and 500 count on back order and the company estimates a release date of late-June 2019.

Pfizer has Calan SR 180 mg extended-release tablets on back order and the company estimates a release date of July 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=571 Atropine Ophthalmic Solution June 19, 2019 Reason for the Shortage

Akorn did not provide a reason for the atropine ophthalmic solution shortage.

Altaire has homatropine ophthalmic solution available.

Estimated Resupply Dates Akorn has 1% atropine 2 mL vials on back order with an estimated release date of late-June 2019.

There are short-dated 1% atropine 15 mL vials available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=514 Clomiphene Citrate Tablets June 19, 2019 Reason for the Shortage

Par did not provide a reason for the shortage. They are the sole suppliers of clomiphene citrate tablets.

Estimated Resupply Dates Par has clomiphene citrate 50 mg tablets in 10 count and 30 count unit-dose packs available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=538 Degarelix Acetate Injection June 19, 2019 Reason for the Shortage

Ferring did not provide a reason for the shortage.



Estimated Resupply Dates Ferring has Firmagon 80 mg vials on back order and the company cannot estimate a release date.

Emergency stock is available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=560 Gentamicin Sulfate Ophthalmic Ointment June 19, 2019 Reason for the Shortage

Akorn has Gentak ophthalmic ointment on shortage due to manufacturing delays.

Gentamicin ophthalmic solutions are not affected by this shortage. Estimated Resupply Dates

Akorn has Gentak 3.5 gram tubes on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=412 Immune Globulin, Intravenous or Subcutaneous (Human) June 19, 2019 Reason for the Shortage

Baxalta has HyQvia and Cuvitru on shortage due to increased demand.

CSL Behring has Hizentra and Privigen on shortage due to increased demand.

Grifols has Gamunex-C and Flebogamma on shortage due to increased demand.

Kedrion Biopharma has Gammaked on shortage due to increased demand.

Takeda has Gammagard Liquid on shortage due to increased demand. Estimated Resupply Dates

Baxalta has Cuvitru and HyQvia on allocation and the company is reviewing all orders.

CSL Behring is releasing Hizentra and Privigen regularly and wholesalers are allocating product.

Grifols has all Gamunex-C and Flebogamma presentations on intermittent back order and the company is releasing product as it becomes available.

Kedrion Biopharma has all Gammaked presentations on back order and the company estimates a release date of late-May 2019.

Octapharma has all Octagam presentations on allocation.

Takeda has all Gammagard Liquid presentations on intermittent back order and the company is allocating product as it becomes available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=527 Tacrolimus Capsules June 19, 2019 Reason for the Shortage

Accord has tacrolimus on allocation due to raw ingredient shortage.

Bionpharma did not provide a reason for the shortage.

Lannett has discontinued tacrolimus capsules.

Major did not provide a reason for the shortage.


Sandoz did not provide a reason for the shortage.

Astellas has Prograf available.

The extended-release products such as Astragra XL capsules and Envarsus XR tablets are not affected by this shortage.




Accord has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on allocation.

Bionpharma has tacrolimus 0.5 mg, 1 mg, and 5 mg capsules on back order and the company cannot estimate a release date.

Major has tacrolimus 0.5 mg and 5 mg capsules on back order and the company estimates a release date of late-June 2019. The 1 mg capsules are on back order and the company cannot estimate a release date.

Sandoz has tacrolimus 1 mg and 5 mg capsules on back order with an estimated release date of late-June 2019.

Strides has short-dated tacrolimus 1 mg capsules available with an expiration date of April 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=567 Valsartan Tablets June 20, 2019 Reason for the Shortage


Camber, Major, Solco, and Teva valsartan tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

Major, Solco, and Teva discontinued valsartan tablets in July 2018.

Alembic, Aurobindo, Cadista, Macleods, and Novartis are not affected by this recall.

Aurobindo, Macleods, and Mylan refuse to provide updated availability information.

Lupin is not actively marketing valsartan tablets.

Repackagers may have some presentations affected depending on the source supplier.

Estimated Resupply Dates Camber has valsartan tablets on back order and the company cannot estimate a release date.

Cadista has valsartan 320 mg tablets on back order and the company cannot estimate a release date. All other presentations are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=444 Valsartan and Hydrochlorothiazide Tablets June 20, 2019 Reason for the Shortage


Solco and Teva valsartan/hydrochlorothiazide tablets were affected by the recall. Detailed information on the products is available at https://www.fda.gov/downloads/Drugs/DrugSafety/UCM615703.pdf.

Solco and Teva discontinued valsartan/hydrochlorothiazide tablets in July 2018.

Alembic, Aurobindo, Lupin, Mylan, Macleods, and Novartis are not affected by this recall.

Aurobindo refused to provide updated availability information.

Lupin did not provide a reason for the shortage.

Macleods refuses to provide updated availability information.

Mylan refuses to provide updated availability information.



Repackagers may have some presentations affected depending on the source supplier. Estimated Resupply Dates

Lupin has all valsartan/hydrochlorothiazide presentations on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=445 Sodium Polystyrene Sulfonate Powder June 20, 2019 Reason for the Shortage

CMP Pharma has sodium polystyrene sulfonate on back order due to a raw material shortage. They are using available powder to make suspension.

ECI Pharmaceuticals did not provide a reason for the shortage.

KVK-Tech has sodium polystyrene sulfonate powder available.

Marlex has sodium polystyrene sulfonate powder available.

Sunrise Pharmaceuticals has sodium polystyrene sulfonate powder available.

Trigen did not provide a reason for the shortage.

Estimated Resupply Dates CMP Pharma has sodium polystyrene sulfonate in 454 gram bottles on back order and the company

cannot estimate a release date.

ECI Pharmaceuticals has sodium polystyrene sulfonate in 454 gram bottles on allocation.

Trigen has sodium polystyrene sulfonate in 454 gram bottles on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=523 Sodium Polystyrene Sulfonate Oral or Rectal Suspension June 20, 2019 Reason for the Shortage

CMP Pharma reports that increased demand has led to a shortage of raw material required to manufacture the products. They are using available powder to manufacture the suspension.

Perrigo has temporarily discontinued their Kionex suspension and sodium polystyrene sulfonate (sorbitol-free) suspension. They cannot estimate when these products will be manufactured again.

Hikma is not currently marketing sodium polystyrene sulfonate suspension.

Estimated Resupply Dates CMP Pharma has SPS Suspension on allocation and the company is shipping supplies regularly.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=430 Recombinant Zoster Vaccine (Shingrix) June 20, 2019 Reason for the Shortage

GlaxoSmithKline has Shingrix on shortage due to high demand for the product. Estimated Resupply Dates

GlaxoSmithKline has Shingrix on intermittent back order and the company is shipping orders according to order date and supply available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=427 Prednisolone Acetate 1% Ophthalmic Suspension June 20, 2019 Reason for the Shortage

Allergan did not provide a reason for the shortage.

Greenstone did not provide a reason for the shortage.



Novartis discontinued Omnipred 1% in 2018.

Sandoz had prednisolone acetate on shortage due to increased demand. Estimated Resupply Dates

Greenstone has all prednisolone acetate 1% presentations on back order and the company estimates a release date of late-June 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=536 Morphine Sulfate Immediate-Release Tablets June 20, 2019 Reason for the Shortage


Estimated Resupply Dates Hikma has morphine 15 mg and 30 mg immediate-release tablets in 100 count bottles on allocation.

Morphine 15 mg immediate-release tablets in 100 count unit-dose packages are on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=504 Mineral Oil and Petrolatum Ophthalmic Ointment June 20, 2019 Reason for the Shortage

Allergan states the shortage is due to production delays.

Bausch Health has Soothe Night Time ointment available.


Alcon states the shortage is due to manufacturing issues.

Perrigo discontinued Puralube ointment products in early-2019.

Rugby discontinued Artificial Tears 3.5 gram tubes in January 2019.

Estimated Resupply Dates Alcon has Systane Nighttime ointment and Genteal PM ointment on back order and the company

estimates a release date in late-June 2019 for Genteal PM and early-July 2019 for Systane.

Allergan has Refresh PM, Lacri-Lube SOP ointment 3.5 gram, and Lacri-Lube SOP ointment 7 gram tubes on back order and the company estimates a release date in late-summer 2019.

Major has Lubrifresh PM 3.5 gram tubes on back order and the company estimates a release date of October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=435 Lorazepam Tablets June 20, 2019 Reason for the Shortage

Aurobindo refuses to provide availability information.


Mylan has discontinued all bottled presentations.

Mylan Institutional discontinued all unit-dose blister pack presentations.

Sandoz discontinued all lorazepam presentations. Estimated Resupply Dates

Major has lorazepam 0.5 mg and 1 mg tablets in 100 count bottles on back order and the company cannot estimate release dates. The 0.5 mg and 1 mg tablets in 100 count unit-dose packages are on back order and the company estimates a release date of late-June 2019.




Isocarboxazid Tablets June 20, 2019 Reason for the Shortage

Validus has Marplan tablets on shortage due to manufacturing delays. They are in the process of transferring manufacturing sites in the US.

Estimated Resupply Dates Validus has Marplan on long-term back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=411 Immune Globulin, Intravenous or Subcutaneous (Human) June 20, 2019 Reason for the Shortage

Baxalta has HyQvia and Cuvitru on shortage due to increased demand.

CSL Behring has Hizentra and Privigen on shortage due to increased demand.

Grifols has Gamunex-C and Flebogamma on shortage due to increased demand.

Kedrion Biopharma has Gammaked on shortage due to increased demand.

Takeda has Gammagard Liquid on shortage due to increased demand. Estimated Resupply Dates

Baxalta has Cuvitru and HyQvia on allocation and the company is reviewing all orders.

CSL Behring is releasing Hizentra and Privigen regularly and wholesalers are allocating product.

Grifols has all Gamunex-C and Flebogamma presentations on intermittent back order and the company is releasing product as it becomes available.

Kedrion Biopharma has all Gammaked presentations on back order and the company estimates a release date of late-May 2019.

Octapharma has all Octagam presentations on allocation.

Takeda has all Gammagard Liquid presentations on intermittent back order and the company is allocating product as it becomes available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=527 Hydroxyethyl Starch in Sodium Chloride Injection June 20, 2019 Reason for the Shortage

BBraun has Hespan available.

Pfizer has 6% hetastarch in 0.9% sodium chloride injection available.

Pfizer has Voluven available.


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=454 Dorzolamide 2% and Timolol 0.5% Ophthalmic Solution June 20, 2019 Reason for the Shortage

Akorn has dorzolamide and timolol ophthalmic solution on shortage due to manufacturing delays.

Sandoz did not provide a reason for the shortage.

Teva discontinued dorzolamide and timolol ophthalmic solution in April 2018.

Bausch Health had dorzolamide and timolol ophthalmic solution on shortage due to manufacturing delays.




Akorn has Cosopt 2%/0.5% ophthalmic solution in 0.2 mL unit-dose packages and 10 mL bottles temporarily unavailable and the company cannot estimate a release date. The dorzolamide 2% and timolol 0.5% ophthalmic solution in 10 mL bottles are on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=360 Dexmedetomidine Hydrochloride 100 mcg/mL Vials for Injection June 20, 2019 Reason for the Shortage

Accord has dexmedetomidine vials available.

Akorn is no longer manufacturing dexmedetomidine vials.

Athenex has dexmedetomidine vials available.

AuroMedics has dexmedetomidine vials available.

Fresenius Kabi has dexmedetomidine vials available.

Hikma has dexmedetomidine vials available.


Par has dexmedetomidine vials available.

Pfizer has dexmedetomidine vials available.

Sandoz has dexmedetomidine vials available.

Sun Pharma is no longer manufacturing dexmedetomidine.

Teva did not provide a reason for the temporary discontinuation of dexmedetomidine vials.

WG Critical Care has dexmedetomidine vials on back order due to manufacturing delays.

Estimated Resupply Dates Teva has temporarily discontinued dexmedetomidine 100 mcg/mL 2 mL vials and the company

cannot estimate a resupply date.

WG Critical Care has dexmedetomidine 100 mcg/mL 4 mL and 10 mL vials on intermittent back order and the company is releasing supplies as they become available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=491 Cyclosporine Injection June 20, 2019 Reason for the Shortage

Novartis has Sandimmune available.


Estimated Resupply Dates Perrigo has cyclosporine 50 mg/mL 5 mL ampules on back order and the company estimates a


https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=534 Carisoprodol Tablets June 20, 2019 Reason for the Shortage

Cadista discontinued carisoprodol tablets.

Endo Pharmaceuticals discontinued carisoprodol tablets.

Mylan discontinued generic carisoprodol tablets.

Rising discontinued carisoprodol tablets.

Estimated Resupply Dates Mylan, the manufacturer of Soma, refuses to provide availability information.



Teva has all presentations on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=558 Bisacodyl Suppositories June 20, 2019 Reason for the Shortage

G&W Laboratories discontinued bisacodyl suppositories.

Major has bisacodyl suppositories on shortage due to increased demand.

Perrigo has bisacodyl suppositories on shortage due to increased demand.

Rugby Laboratories has bisacodyl suppositories on shortage due to increased demand.

Estimated Resupply Dates Major has all bisacodyl suppositories on back order and the company cannot estimate a release date.

Perrigo has all bisacodyl suppositories on back order. The company estimates a release date of mid-July 2019 for the 12 count presentation and mid-August 2019 for the 50 count presentation.

Rugby Laboratories has all bisacodyl suppositories on back order and the company cannot estimate a release date.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=565 Azithromycin Injection June 20, 2019 Reason for the Shortage

Apotex has discontinued azithromycin injection.


Fresenius Kabi has azithromycin injection on shortage due to increased demand.

Pfizer has azithromycin injection on shortage due to manufacturing delays.

Sun Pharma is not currently manufacturing azithromycin injection.

Estimated Resupply Dates AuroMedics has azithromycin 500 mg vials on intermittent back order and the company is releasing

product as it becomes available.

Pfizer has azithromycin 500 mg ADD-Vantage vials on back order and the company estimates a release date of March 2020. Zithromax 500 mg vials are on back order and the company estimates a release date of October 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=380 Sodium Acetate Injection June 21, 2019 Reason for the Shortage

American Regent is not currently marketing sodium acetate injection.

Fresenius Kabi has sodium acetate injection on back order due to increased demand.

Pfizer has sodium acetate injection on shortage due to manufacturing delays.

Estimated Resupply Dates Fresenius Kabi has sodium acetate 4 mEq/mL 100 mL vials on back order and the company estimates

a release date of mid-July 2019.

Pfizer has sodium acetate 2 mEq/mL 20 mL vials available in limited supply. The 50 mL and 100 mL vials are on back order and the company estimates a release date of August 2019.




Sincalide Injection June 21, 2019 Reason for the Shortage

Bracco Diagnostics has Kinevac injection on shortage due to a supply disruption.

There are no approved alternatives to Kinevac for the labeled indications.

Estimated Resupply Dates Bracco has Kinevac on intermittent back order and the company releases product as it becomes

available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=277 Ondansetron Hydrochloride Injection June 21, 2019 Reason for the Shortage

Apotex has ondansetron injection available.

Athenex had ondansetron injection on shortage due to increased demand.


Fresenius Kabi has ondansetron injection available.

Heritage had ondansetron on shortage due to increased demand. Heritage discontinued ondansetron 2 mg/mL 2 mL vials in 10 count in late-2018.



Pfizer has ondansetron injection on shortage due to manufacturing delays.

Sagent has ondansetron injection on shortage due to increased demand and manufacturing delays.

Novartis discontinued Zofran 20 mL vials in May 2018.

Estimated Resupply Dates AuroMedics has ondansetron 2 mg/mL 2 mL vials and 20 mL vials on intermittent back order and the

company is releasing supplies as they become available.

Fresenius Kabi has ondansetron 2 mg/mL 20 mL vials on back order and the company cannot estimate a release date.

Hikma has ondansetron 2 mg/mL 20 mL vials in 1 count and 10 count on back order and the company cannot estimate a release date.

Pfizer has ondansetron 2 mg/mL 2 mL iSecure syringes on back order and the company estimates a release date of August 2020. The 2 mg/mL 20 mL vials are on back order and the company estimates a release date in September 2019. The 2 mg/mL 2 mL vials are available in limited supply.

Sagent has ondansetron 2 mg/mL 2 mL vials and 20 mL vials on back order and the company estimates a release date of August 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=405 Octreotide Injection June 21, 2019 Reason for the Shortage

Fresenius Kabi has octreotide injection on back order due to increased demand.


Mylan Institutional refuses to provide availability updates.

Sagent has octreotide on shortage due to increased demand.

Sun Pharma is not currently marketing octreotide.


Novartis has Sandostatin available. The 200 mcg/mL 5 mL vials were discontinued in early-2018.



Estimated Resupply Dates Fresenius Kabi has octreotide 100 mcg/mL 1 mL vials on back order and the company estimates a

release date of early-July 2019. The 500 mcg/mL 1 mL vials are on back order and the company estimates a release date of late-August 2019.

Hikma has octreotide 100 mcg/mL 1 mL vials, 500 mcg/mL 1 mL vials, 200 mcg/mL 5 mL vials, and 1000 mcg/mL 5 mL vials on back order and the company cannot estimate a release date.

Sagent has ocreotide 50 mcg/mL 1 mL vials, 100 mcg/mL 1 mL vials, 200 mcg/mL 5 mL vials, and 500 mcg/mL 1 mL vials on back order and the company estimates a release date of August 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=229 Levothyroxine Sodium Injection June 21, 2019 Reason for the Shortage

Athenex started marketing levothyroxine sodium in January 2019

Fresenius Kabi has levothyroxine sodium available.

Par had levothyroxine sodium on shortage due to increased demand.

Piramal Critical Care did not provide a reason for the shortage.

Estimated Resupply Dates Par has levothyroxine 200 mcg vials on back order and the company estimates a release date of July

2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=506 Ampicillin Sodium and Sulbactam Sodium Injection June 21, 2019 Reason for the Shortage

AuroMedics has ampicillin sulbactam vials on back order due to increased demand and manufacturing delays.

Pfizer has discontinued generic ampicillin sulbactam except for the 1.5 gram and 3 gram ADD-Vantage vials.

Sagent has ampicillin sulbactam vials on back order due to manufacturing delays and increased demand.

Sandoz cannot provide a reason for the shortage.

WG Critical Care states the shortage is due to increased demand.

Mylan Institutional refuses to provide availability information

Estimated Resupply Dates AuroMedics has ampicillin sulbactam 3 gram, and 15 gram vials on intermittent back order and the

company is releasing product as it becomes available. The 1.5 gram vials are on back order and the company estimates a release date of July 2019.

Fresenius Kabi has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

Hikma has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the company cannot estimate a release date.

Pfizer has Unasyn 1.5 gram, 3 gram, and 15 gram bulk vials are on back order and the company estimates a release date of August 2019. The 1.5 gram and 3 gram ADD-Vantage vials are on back order and the company estimates a release date of September 2019.

Sandoz has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on long-term back order and the company cannot estimate a release date.

Sagent has ampicillin sulbactam 1.5 gram vials, 3 gram vials, and 15 gram bulk vials on back order and the company cannot estimate a release date.



WG Critical Care has ampicillin sulbactam 1.5 gram, 3 gram, and 15 gram vials on back order and the company estimates a release date of early-to mid-July 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=159 Diltiazem Hydrochloride Injection June 23, 2019 Reason for the Shortage

Akorn states the reason for the shortage was increased demand due to market conditions. They are not currently producing the 25 mL vials in 10 count.

Pfizer states the reasons for the shortage is manufacturing delays and increases in demand.

Hikma has diltiazem injection on shortage due to manufacturing delays caused by increased demand due to current market conditions.

Estimated Resupply Dates Hikma has diltiazem 5 mg/mL 25 mL vials on allocation.

Pfizer has 100 mg ADD-Vantage vials on back order and the company estimates a release date of July 2019. The 5 mg/mL 5 mL and 10 mL vials are also on back order and the company estimates a release date of March 2020 for the 5 mL vials and August 2019 for the 10 mL vials.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=26 Diazepam Injection June 23, 2019 Reason for the Shortage

Pfizer has diazepam on shortage due manufacturing delays.

DASH Pharmaceuticals launched diazepam injection in early-April 2019.

Estimated Resupply Dates Pfizer has diazepam 5 mg/mL 2 mL Carpuject syringes available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=330 Calcium Chloride Injection June 23, 2019 Reason for the Shortage

American Regent did not provide a reason for the shortage.

Amphastar has calcium chloride on shortage due to increased demand.

Pfizer has calcium chloride on shortage due to manufacturing delays.

Mylan Institutional has withdrawn calcium chloride syringes from the market. The company recalled the syringes in April 2015 due to incompatibility of the syringes and some needless adaptors.

Estimated Resupply Dates American Regent has calcium chloride 100 mg/mL 10 mL vials available in limited supply.

Amphastar has calcium chloride 100 mg/mL 10 mL syringes available in limited supply.

Pfizer has calcium chloride 100 mg/mL 10 mL Ansyr syringes and 100 mg/mL 10 mL LifeShield syringes on back order and the company estimates a release date of August 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=48 Nelarabine Injection June 24, 2019 Reason for the Shortage

Novartis did not provide a reason for the shortage.




Novartis has Arranon 5 mg/mL 50 mL vials on a limited allocation. https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=458 Lidocaine with Epinephrine Injection June 24, 2019 Reason for the Shortage

Fresenius Kabi has Xylocaine with epinephrine presentations on shortage due to increased demand for the product and manufacturing delays.

Pfizer has lidocaine with epinephrine presentations on shortage due to manufacturing delays.

Estimated Resupply Dates Fresenius Kabi has 1% Xylocaine with epinephrine (1:200,000) 10 mL vials on back order and the

company estimates release dates of late-June 2019. The 1% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates release dates of early-July 2019. The 1% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates release dates of late-June 2019. The 1% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 1.5% Xylocaine-MPF with epinephrine (1:200,000) 30 mL vials in sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of early-July 2019. The 2% Xylocaine with epinephrine (1:200,000) 50 mL vials are on back order and the company estimates a release date of early- to mid-July 2019. The 2% Xylocaine-MPF with epinephrine (1:200,000) 20 mL vials in sterile packs are on back order and the company cannot estimate a release date. Check wholesalers for inventory.

Pfizer has 1% lidocaine with epinephrine (1:100,000) 20 mL vials on back order and the company estimates a release date of June 2019. The 1% lidocaine with epinephrine (1:100,000) 30 mL vials are on back order and the company estimates a release date of July 2019. The 1% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of June 2019. The 1.5% lidocaine with epinephrine (1:200,000) 30 mL vials are on back order and the company estimates a release date of July 2019. The 1.5% lidocaine with epinephrine (1:200,000) 5 mL glass ampules are on back order and the company estimates a release date of July 2019. The 2% lidocaine with epinephrine (1:100,000) 20 mL vials are on back order and the company estimates a release date of June 2019. The 2% lidocaine with epinephrine (1:100,000) 30 mL vials are on back order and the company estimates a release date of July 2019. The 2% lidocaine with epinephrine (1:100,000) 50 mL vials are on back order and the company estimates a release date of June 2019.The 2% lidocaine with epinephrine (1:200,000) 20 mL vials are on back order and the company estimates a release date of July 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=98 Lidocaine Injection June 24, 2019 Reason for the Shortage

Amphastar had lidocaine 2% emergency syringes on shortage due to increase demand for the product.

AuroMedics introduced lidocaine injection in February 2014.

Fresenius Kabi had generic lidocaine presentations on shortage due to a supply interruption of raw ingredients.

Pfizer has lidocaine presentations on shortage due to manufacturing delays.




Amphastar has 2% lidocaine 5 mL syringes on intermittent back order and the company is releasing product as it becomes available.

AuroMedics has 1% lidocaine 5 mL ampules and 5 mL vials on intermittent back order and the company is releasing product as it becomes available. AuroMedics has 2% lidocaine 5 mL vials on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has lidocaine 2 mL vials on back order and the company estimates a release date of late-July 2019. The 1% Xylocaine-MPF 30 mL vial sterile packs are on back order and the company cannot estimate a release date. The 2% Xylocaine-MPF 10 mL ampules are on back order and the company estimates a release date of 3rd quarter 2019. Check wholesalers for inventory.

Hikma has 2% lidocaine 5 mL vials on back order and the company estimates a release date of July 2019.

Pfizer has 1% lidocaine 5 mL preservative-free ampules on back order and the company estimates a release date of March 2020. The 1% lidocaine 20 mL vials are available in limited supply. The 1% lidocaine 30 mL preservative-free vials are on back order and the company estimates a release date of July 2019. The 1% lidocaine 50 mL vials are on back order and the company estimates a release date of August 2019. The 1% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of August 2019. The 1.5% lidocaine 20 mL preservative-free ampules are on back order and the company estimates a release date of September 2019. The 2% lidocaine 10 mL ampules are available in limited supply. The 2% lidocaine 5 mL vials are on back order and the company estimates a release date of June 2019. The 2% lidocaine 20 mL and 50 mL vials are on intermittent back order and the company is releasing product as it becomes available. The 2% lidocaine 5 mL Lifeshield syringes are on back order and the company estimates a release date of August 2019. The 2% lidocaine 5 mL Ansyr syringes are on back order and the company estimates a release date of August 2019. The 4% lidocaine 5 mL ampules are available in limited supply.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=88 Leucovorin Calcium Injection June 24, 2019 Reason for the Shortage

Fresenius Kabi had leucovorin on shortage due to manufacturing delays and increased demand.

Hikma did not provide a reason for the current shortage.


Sagent has leucovorin on shortage due to manufacturing delays.

Teva has leucovorin available.

Estimated Resupply Dates Fresenius Kabi has leucovorin 200 mg vials on back order and the company estimates a release date

of mid-July 2019.

Hikma has leucovorin 50 mg, 200 mg, and 350 mg vials on back order and the company estimates a release date of July 2019 for the 50 mg and 200 mg vials and late-June to early-July 2019 for the 350 mg vials. There are short-dated 100 mg vials available with an expiration date of < May 2020.

Sagent has leucovorin 50 mg, 100 mg, 200 mg, 350 mg, and 500 mg vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=35 Iopromide Injection June 24, 2019 Reason for the Shortage

Bayer did not provide a reason for the shortage. Ultravist is sold through McKesson Specialty.

Bayer is the sole supplier of iopromide injection.




Bayer has all Ultravist presentations on back order and the company does not expect product to be released until 2020.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=577 Estradiol Valerate Injection June 24, 2019 Reason for the Shortage


Par has Delestrogen available.

Estimated Resupply Dates All marketed presentations are available.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=570 Erythromycin Ophthalmic Ointment June 24, 2019 Reason for the Shortage

Akorn did not provide a reason for the shortage.

Bausch Health did not provide a reason for the shortage.

Perrigo has erythromycin ophthalmic ointment on shortage due to increased demand.

Estimated Resupply Dates Akorn has erythromycin 0.5% ophthalmic ointment in 3.5 gram tubes on back order and the

company is allocating product when it becomes available. The 1 gram tubes are on allocation.

Bausch Health has erythromycin 0.5% ophthalmic ointment in 1 gram and 3.5 gram tubes on back order and the company estimates a release date of early- to mid-July 2019 for the 1 gram tubes and mid-July 2019 for the 3.5 gram tubes.

Perrigo has erythromycin 0.5% ophthalmic ointment in 1 gram tubes in 50 count on back order and the company estimates a release date of early- to mid-July 2019. The 3.5 gram tubes in 24 count are on back order and the company estimates a release date of early-July 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=540 Doxycycline Hyclate Injection June 24, 2019 Reason for the Shortage


Zydus did not provide a reason for the shortage.

Estimated Resupply Dates Zydus has doxycycline 100 mg vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=559 Dexmedetomidine Hydrochloride 4 mcg/mL Premix for Injection June 24, 2019 Reason for the Shortage


WG Critical Care began marketing premixed bags in November 2018.

Baxter has dexmedetomidine premixed bags available.

Estimated Resupply Dates All marketed presentations are available.




Dexamethasone Sodium Phosphate Injection June 24, 2019 Reason for the Shortage

American Regent is not marketing dexamethasone sodium phosphate injection at this time.

AuroMedics has dexamethasone sodium phosphate on intermittent back order.

Fresenius Kabi has dexamethasone sodium phosphate presentations available.



Estimated Resupply Dates AuroMedics has dexamethasone sodium phosphate 4 mg/mL 1 mL, 5mL, and 30 mL vials on

intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has dexamethasone sodium phosphate 10 mg/mL 1 mL preservative-free vials on back order and the company estimates a release date of late-June 2019. The 4 mg/mL 1 mL and 30 mL vials are on back order and the company estimates a release date of late-June 2019 for the 1 mL vials and early-July 2019 for the 30 mL vials. The 10 mg/mL 10 mL vials are on back order and the company estimates a release date of late-June 2019. There are short-dated 4 mg/mL 1 mL prefilled syringes available with an expiration date of <9 months.

Hikma has dexamethasone sodium phosphate 4 mg/mL 1 mL vials on allocation.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=140 Clotrimazole Lozenges (Clotrimazole Troches) June 24, 2019 Reason for the Shortage


Perrigo has clotrimazole lozenges on shortage due to increased demand.

Estimated Resupply Dates Hikma has clotrimazole 10 mg lozenges in 70 count and 140 count bottles on allocation. The 10 mg

lozenges in 70 count unit-dose packs are on allocation.

Perrigo has clotrimazole 10 mg lozenges in 70 count bottles on back order and the company estimates a release date of August 2019. The 10 mg lozenges in 140 count bottles are on back order and the company estimates a release date of September 2019. The 10 mg lozenges in 70 count unit-dose packs are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=541 Bupivacaine with Epinephrine Injection June 24, 2019 Reason for the Shortage

Fresenius Kabi has bupivacaine and epinephrine on shortage due to increased demand and manufacturing delays.

Pfizer has bupivacaine with epinephrine on shortage due to manufacturing delays.

Estimated Resupply Dates Fresenius Kabi has 0.25% Sensorcaine-MPF with epinephrine 10 mL vials on back order and the

company estimates a release date of late-June 2019. The 0.25% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of early-July 2019. The 0.5% Sensorcaine-MPF with epinephrine 10 mL vials are on back order and the company estimates a release date of early- to mid-July 2019. The 0.5% Sensorcaine-MPF with epinephrine 30 mL vials are on back order and the company estimates a release date of mid-July 2019. The 0.5% Sensorcaine-



MPF with epinephrine 30 mL sterile packs are on back order and the company cannot estimate a release date.

Pfizer has 0.25% bupivacaine with epinephrine 30 mL preservative-free vials on back order and the company estimates a release date of December 2019. The 0.25% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of November 2019. The 0.25% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of December 2019. The 0.5% bupivacaine with epinephrine 10 mL preservative-free vials are on back order and the company estimates a release date of February 2020. The 0.5% bupivacaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of June 2019.The 0.5% bupivacaine with epinephrine 50 mL vials are on back order and the company estimates a release date of December 2019.

Pfizer has 0.25% Marcaine with epinephrine 10 mL preservative-free vials on back order and the company estimates a release date of September 2019. The 0.25% Marcaine with epinephrine 30 mL preservative-free vials are on back order and the company estimates a release date of July 2019. The 0.25% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of June 2021. The 0.5% Marcaine with epinephrine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine with epinephrine 50 mL vials are on back order and the company estimates a release date of September 2019.

https://www.ashp.org/Drug-Shortages/Current-Shortages/Drug-Shortage-Detail.aspx?id=261 Bupivacaine Injection June 24, 2019 Reason for the Shortage

AuroMedics has not provided a reason for the shortage.

Fresenius Kabi had Sensorcaine on shortage due to increased demand for the product.

Pfizer has bupivacaine on shortage due to manufacturing delays. Pfizer discontinued 0.5% bupivacaine 30 mL glass ampules in December 2017.

Estimated Resupply Dates AuroMedics has 0.25% bupivacaine 10 mL and 30 mL preservative-free vials on intermittent back

order and the company is releasing product as it becomes available. The 0.5% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available. The 0.75% bupivacaine 10 mL and 30 mL preservative-free vials are on intermittent back order and the company is releasing product as it becomes available.

Fresenius Kabi has 0.25% Sensorcaine 30 mL preservative-free vials on back order and the company estimates a release date of late-June 2019. The 0.5% Sensorcaine 50 mL vials are on back order and the company estimates a release date of mid-July 2019. The 0.25% and 0.5% Sensorcaine 30 mL preservative-free vials in sterile packs are on back order and the company cannot estimate release dates.

Pfizer has 0.25% bupivacaine 10 mL preservative-free vials on back order and the company estimates a release date of August 2019. The 0.25% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of July 2019. The 0.25% bupivacaine 50 mL vials are on back order and the company estimates release dates of August 2019. The 0.5% bupivacaine 10 mL preservative-free vials are on back order and the company estimates a release date of December 2019. The 0.5% bupivacaine 30 mL preservative-free vials are available in limited supply. The 0.5% bupivacaine 50 mL vials are on back order and the company estimates a release date of June 2019. The 0.75% bupivacaine 30 mL preservative-free vials are on back order and the company estimates a release date of August 2019.



Pfizer has 0.25% Marcaine 10 mL and 30 mL preservative-free vials on back order and the company estimates a release date of September 2019 for the 10 mL vials and July 2019 for the 30 mL vials. The 0.25% 50 mL vials are on back order and the company estimates a release date of January 2020. The 0.5% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of November 2019 for the 10 mL vials and January 2020 for the 30 mL vials. The 0.5% 50 mL vials are on back order and the company estimates a release date of October 2019. The 0.75% Marcaine 10 mL and 30 mL preservative-free vials are on back order and the company estimates a release date of January 2020.


*Please refer to ASHP website for more information at: https://www.ashp.org/Drug-Shortages/Current-Shortages

https://www.ashp.org/Drug-Shortages/Current-Shortages

https://www.ashp.org/Drug-Shortages/Current-Shortages

Documents

Drug Information Update - PerformRx Information Update June...saxagliptin hcl 5 mg-5 mg tablet new strength tx for adhd/narcolepsy adhansia xr methylphenidate hcl 25, 35, 45, 55, 70,