F.No.

l3-73 /2020-QC MOST IMMEDIATE

Government of Pakistan THROUGH COURRJER
Drug Regulatory Authority of Pakistan
Ministry of National Health Services,
.--rF-F
Regulations & Coordination
Islamabad
**********
Islamabad, the 2 I't December, 2020.

[Medical Product Alert]

I\{/s GlaxoSmithKline Pakistan Limited,
35- Dockyard Road, West Wharf
Karachi.

Subject: RECALL OF PRODUCTS DUE TO PRINTING MISMATCH WITH

RESPECT TO PRODUCT SPECIFICATIONS.

I Nil dated 05ft November,2020 & 20th

am directed to refer to your letters vide No.
November, 2020 wherein you have informed regarding printing mismatch with respect to
product specifications on packaging of following product batches;

S. No. Product Name Batch No.

I Velosef Capsule 25Omg ME7H, CH6Y, CH6X, MD3L, MD3N
923N, 924H, C38K, C38M, C38N, FY6F, JFZH,
2. Velosef Capsule 25Omg
JF2M, JF2J
X83R, X83T, 6P3C, 6P2N, 6P3H, KE4V, KE4W,
3 Capoten Tablet 25mg
KE4X, KE4Y, V24M, V24N
4. Capoten Tablet 50mg 4G4F, CA9D, CA9E
8L6T, NC4B, NC7N, NC4K, UX6K, UX6L,
5 Fixval Suspension l00mg
VC6P, VC6R
6 Ceporex Capsule 500mg T57L
4G38, 4G3D, JE4Y, JE8A, JW7U, S43X, S47K,
7 Quibron SR Tablet
547L, VY8F
8 Zinacef Tablet 250mg P37E, W38W

02. You are therefore advised to recall all the stocks of above-mentioned batches of
products, alert your sales officers/suppliersi distributors to issue instructions to the
pharmacies/hospitals, point of sales/purchase/use for the return of stocks of products in
question. It shall be ensured that compliance report to this effect should reach to this division
within seven (07) days positively
l
I
(HAFIZ SaN,{Ur,r,AH BABAR)
Assistant Director (QC-I[)
Copv for information and necessarv action - with reouest to issue necessarv directions to noints
of use/sale (Hosoitals Pharmacies. Medical stores. Distributors. Whole sellers. etc) under
administrative control/ fall under area of iurisdiction. please.

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

2. The Secretary Primary and Secondary Health Department (Covernment of Punjab)
3. The Secretary Health Department (Govemment of Sindh).
4. The Secretary (SHC&ME) Health Department (Government of KPK).
5. The Secretary (SHC&ME) Health Department (Government of Baluchistan).
6. The Secretary (SHC&ME) Health Department (Government of AJ&K).
7. The Director General Health, M/o NHSR&C, Islamabad.
8. The Director General Health, Government of Punjab.
9. The Director General Health, Government of Sindh.
10. The Director General Health, Government of KPK.
I l. The Director General Health, Government 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, Islamabad.
16. The Additional Director DRAP, Peshawar.
17. The Additional Director DRAP, Quetta.
18. The Chief Drug Inspector Baluchistan.
19. The Chief Drug Controller Punjab.
20. The Chief Drug Inspector Sindh.
21. The Chief Drug Inspector KPK.
22.The Chief Drug Inspector G.B.
23. The Chief Drug Inspector AJ&K.
24. Senior Drug Inspector, ICT, Islamabad.

Copy to: -
i. The Director, QA&LT, DRAP, Islamabad.
;f' Tl're Additional Director MIS with request to upload it on official website in the larger interest of
public.
iii. The Area, FID, DRAP, Karachi for information, record and necessary action please.
iv. PS to CEO, DRAP, Islamabad
v. Office copy.

Assistant Director (QC-ID