Drug product
Valsartan and Hydrochlorothiazide (HCTZ) Tablets, USP 320 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 0591-2318-19
D-0984-2018
Product summary
- Event
- Event 80538
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 64,168 bottles
- Official record key
drug-enforcement:D-0984-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot Numbers: 1191185M, 1191186M, 1225615M, 1233948M, 1250718M, 1253257M
Distribution pattern: Product was distributed throughout the United States, including Hawaii and Puerto Rico
Derived failure modes
-
Manufacturing or process control
CGMP Deviations