Drug product
Valsartan 320 mg tablets, 90-count bottles ( NDC 71335-0567-2), Rx Only, Packaged by Bryant Ranch, Burbank, CA 91504.
D-1029-2018
Product summary
- Event
- Event 80634
- Status
- Terminated
- Classification
- Class II
- Quantity
- 90 tablets
- Official record key
drug-enforcement:D-1029-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Lot # 120879; Exp 10/19
Distribution pattern: Product was distributed in HI, IN, and FL.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations