Drug product
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 160 mg/12.5 mg tablets, USP 90-count bottle, Rx Only, Rx Only, Manufactured by: Arrow Pharma (Malta) Ltd. India, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054. NDC 0591-2316-19.
D-0982-2018
Product summary
- Event
- Event 80538
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 195,234 bottles
- Official record key
drug-enforcement:D-0982-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot Numbers: 1191160M, 1191161M, 1191162A, 1219363M, 1219364M, 1219365A, 1225613A, 1233944M, 1233945M, 1253253M, 1253254M
Distribution pattern: Product was distributed throughout the United States, including Hawaii and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations