Drug product
Valsartan Tablets, USP 320 mg, 90-count bottle (NDC 0591-2170-19), 500-count bottle (NDC 0591-2170-05), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054.
D-0989-2018
Product summary
- Event
- Event 80538
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 13,555 90-count bottles; 2,892 500-count bottles
- Official record key
drug-enforcement:D-0989-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: NDC 0591-2170-19 Lot Numbers: 1208002A, 1247282M, 1263944M NDC 0591-2170-05 Lot Numbers: 1208000M, 1208001M, 1240425A
Distribution pattern: Product was distributed throughout the United States, including Hawaii and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations