Drug product
AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-888-90
D-1177-2018
Product summary
- Event
- Event 80940
- Status
- Terminated
- Classification
- Class II
- Quantity
- 19623 bottles
- Official record key
drug-enforcement:D-1177-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lots: 17308 Exp. 09/2018; 18158 Exp. 09/2018; 18539 Exp. 01/2019; 19021 Exp. 01/2019; 19225 Exp. 01/2019; 20033 Exp. 06/2019; 20290 Exp. 06/2019; 20565 Exp. 06/2019; 21369 Exp. 10/2019
Distribution pattern: Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations