Drug product
AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-884-90
D-1173-2018
Product summary
- Event
- Event 80940
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12240 bottles
- Official record key
drug-enforcement:D-1173-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lots: 17349 Exp. 08/2018; 18395 Exp. 08/2018; 19221 Exp. 06/2019; 20029 Exp. 06/2019; 20158 Exp. 07/2019; 20843 Exp. 07/2019; 21411 Exp. 09/2019.
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations