Drug product
Valsartan Tablets, USP 40 mg, 30-count bottle (NDC 0591-2167-30), 90-count bottle (NDC 0591-2167-19), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
D-0986-2018
Product summary
- Event
- Event 80538
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 8,046 30-count bottles, 20,841 90-count bottles
- Official record key
drug-enforcement:D-0986-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot Numbers: NDC 0591-2167-30 1196936A, 1238463A, 1270617A NDC 0591-2167-19 1196934M, 1238462M, 1268429A
Distribution pattern: Product was distributed throughout the United States, including Hawaii and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations