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F.No.03-39/2020-QCGovernment of Pakistan

Drug Regulatory Authority of PakistanMinistry of National Health Services,

Regulation & Coordination,

.l',liT:P3f-lslamabad, the 0l't October,2020.

[Medical Product Alert]"Medisol Compound Sodium Lactate IV Infusion 500m1"

M/s Medipak Limited,1321 l, Industrial Estate, Kot Lakhpat,Lahore.

Subject: RECALL OF MEDISOL UND SODIUM LACTATE IVINFUSION sOOML.

I am directed to the letter from Medical Superintendent, DHQ Hospital, Kotri,

Jamshoro and further inspection of pharmacy of said hospital by Area Federal Inspector of

Drugs, DRAP, Karachi whereby your following product was found containing clearly visible

blackish material that can be harmful for the patients;

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Product Name:

Generic Name:

Manufacturer:

Batch Number:

Medisol Compound Sodium Lactate IV Infusion 500m1

Sodium Lactate (Ringer Lactate)

IWs Medipak Limited, Lahore.

909771

02. You are therefore advised to recall all the stocks of suspected batch of product, alert

your sales officers/suppliers/ distributors to issue instructions to the pharmacies/hospitals,

point of sales/purchase/use fbr the return of suspected stocks of product in question. It shall

be ensured that compliance report to this effect should reach to this division within seven (07)

days positively

(MUHAMMAD ASHFAQ)Assistant Director QC-I

Copv for information and necessarv action - with request to issue necessarv directions to points ofuse/sale (Hosnitals Pharmacies. Medical stores. Distributors. Whole sellers. etc) under administrativecontrol/ fall under area of iurisdiction. please.

t-/>z

l. The Secretary (SHC&ME) Health Department (Government ol Punjab)'

2. The Secretary Primary and Secondary Health Department (Covernment of Puniab).

3. The Secretary Health Department (Covernment of Sindh).

4. The Secretarl' (SHC&ME) Health Department (Government ol KPK)'

5. The Secretarl, (SHC&ME) Health Department (Cove|nment of Baluchistan ).

6. The Secretary (SHC&ME) Health Department (Government of AJ&K).

7. The Director Cenelal Health, M/o NHSR&C. lslamabad.

8. The Director General Health, Government of Punjab.

9. The Director Ceneral Health, Government of Sindh.

10. The Director Ceneral Health, Government of KPK.

I l. The Director Ceneral Health, Govemment of Baluchistan.

12. The Director General Health, Government of AJ&K'

13. The Additional Director DRAP, Lahore.

14. The Additional Director DRAP, Karachi.

15. The Additional Director DRAP, lslamabad.

16. The Additional Director DRAP. Peshawar.

17. The Additional Director DRAP. Quetta.

18. The Chief Drug Inspector Baluchistan.

19. The Chiel Drug Controller Puniab.

20. The Chief Drug lnspector Sindh.

2l . The Chief Drug lnspector KPK.

22. The Chiel Drug Inspector C.B.

23. The Chief Drug Inspector AJ&K.

24. Senior Drug Inspector. lCT. lslamabad.

Copy to: -i. - The Director, QA&LT, DRAP, lslamabad.

6 The Additional Director MIS with request to upload it on ollicial website in the

public.iii. The Area FID, DRAP, Lahore for information record and necessary action please.

iv. PS to CEO, DRAP, Islamabad.

v. Office copy.

Assistant

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