Drug product
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
D-0967-2018
Product summary
- Event
- Event 80557
- Status
- Terminated
- Classification
- Class II
- Quantity
- 4,556 cartons
- Official record key
drug-enforcement:D-0967-2018
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 160 mg Item # 302087. Lot# T-01269 (Expiry: 7/18). Lot# T-01524 (Expiry: 2/19). Lot# T-01646 (Expiry: 5/19). Lot# T-01668 (Expiry: 5/19). Lot# T-01788 (Expiry: 5/19).
Distribution pattern: Nationwide.
Derived failure modes
-
Manufacturing or process control
CGMP Deviations