Drug product
Valsartan/HCTZ 160/25mg Tablets, 30-count jar, Rx Only, Packaged by NuCare Pharmaceuticals, Inc., Orange, CA 92867,
D-1038-2018
Product summary
- Event
- Event 80701
- Status
- Terminated
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-1038-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot # T11443; Exp. 02/28/2019
Distribution pattern: Distributed to three customers in Fl and CA
Derived failure modes
-
Manufacturing or process control
CGMP Deviations