Drug product
Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-784-15 Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-1131-2018
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 80828
- Status
- Terminated
- Classification
- Class II
- Quantity
- 728 cartons (36,400 tablets)
- Official record key
drug-enforcement:D-1131-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lots: 18492 Exp. 11/2018; 20169 Exp. 05/2019
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations