Drug product
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
D-0966-2018
Product summary
- Event
- Event 80557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,464 cartons
- Official record key
drug-enforcement:D-0966-2018
Official wording
Reason: CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Code information: Major Label Unit Dose 10 x 10 Cartons 80 mg Item # 302086. Lot# T-01270 (Expiry: 7/18). Lot# T-01466 (Expiry: 7/18). Lot# T-01500 (Expiry:2/19). Lot# T-01596 (Expiry: 2/19). Lot# T-01625 (Expiry: 2/19). Lot# T-01712 (Expiry: 2/19). Lot# T-01795 (5/19). Lot# T-01807 (Expiry: 5/19).
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations