Drug product
AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-886-90
D-1176-2018
Product summary
- Event
- Event 80940
- Status
- Terminated
- Classification
- Class II
- Quantity
- 12950 bottles
- Official record key
drug-enforcement:D-1176-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lots: 17780 Exp. 09/2018; 18029 Exp. 09/2018; 18398 Exp. 09/2018; 18723 Exp. 09/2018; 19017 Exp. 02/2019; 19224 Exp. 02/2019; 20032 Exp. 08/2019; 20289 Exp. 08/2019; 21076 Exp. 08/2019; 21382 Exp. 08/2019
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations