Drug product
Valsartan 320 mg tablets, 30-count bottles ( NDC 63629-6905-1), 90-count bottles (NDC 63629-6905-2), 28-count bottles (NDC 6362-96905-3), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
D-1028-2018
Product summary
- Event
- Event 80634
- Status
- Terminated
- Classification
- Class II
- Quantity
- 990 tablets
- Official record key
drug-enforcement:D-1028-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot # 114319; Exp. 10/18 Lot # 109004; Exp. 12/18
Distribution pattern: Product was distributed in HI, IN, and FL.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations