Drug product
Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-786-13 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-1133-2018
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 80828
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1496 cartons (44,880 tablets)
- Official record key
drug-enforcement:D-1133-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lots: 17718 Exp. 07/2018; 18700 Exp. 01/2019; 19133 Exp. 02/2019; 19532 Exp. 04/2019
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations