Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.
Recall Number: D-0967-2018
Firm: MAJOR PHARMACEUTICALS
Classification: Class II
Status: Terminated
Report Date: 20180801
Initiation Date: 20180718
Termination Date: 20221002
Reason for Recall
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product Description
Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61. NDC# 0904-6595-61.