Drug recall D-0967-2018

Class II Terminated reported Aug 1, 2018

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.

Reason for recall

CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.

Lots and codes

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).

Recall details

Recalling firm
MAJOR PHARMACEUTICALS, Livonia, MI
Quantity
4,556 cartons
Distribution
Nationwide.
Type
N/A
Recall initiated
July 18, 2018
Terminated
October 2, 2022