Drug product
Valsartan Tablets, USP 160 mg, 90-count bottle (NDC 0591-2169-19), 1000-count bottle (NDC 0591-2169-10), Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054
D-0988-2018
Product summary
- Event
- Event 80538
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 15,347 90-count bottles, 8,378 1000-count bottles
- Official record key
drug-enforcement:D-0988-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: NDC 0591-2169-19 Lot Numbers: 1177880A, 1220831A, 1263941A NDC 0591-2169-10 1175922M, 1220826M, 1236294M, 1240427M, 1270616A
Distribution pattern: Product was distributed throughout the United States, including Hawaii and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations