Drug product
Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit Dose Manufactured for: AvKARE, Inc. Pulaski, TN 38478
D-1130-2018
Product summary
- Firm
- AVKARE Inc.
- Event
- Event 80828
- Status
- Terminated
- Classification
- Class II
- Quantity
- 6776 cartons (338,800 tablets)
- Official record key
drug-enforcement:D-1130-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lots: 18491 Exp. 10/2018; 19531 Exp. 04/2019; 20168 Exp. 05/2019; 20671 Exp. 08/2019; 21049 Exp. 10/2019; 21635 Exp. 10/2019
Distribution pattern: U.S. Nationwide
Derived failure modes
-
Manufacturing or process control
CGMP Deviations