Drug recall D-0966-2018

Class II Terminated reported Aug 1, 2018

Product

Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.

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 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).

Recall details

Recalling firm
MAJOR PHARMACEUTICALS, Livonia, MI
Quantity
5,464 cartons
Distribution
Nationwide.
Type
N/A
Recall initiated
July 18, 2018
Terminated
October 2, 2022