MAJOR PHARMACEUTICALS recalls Unit Dose Valsartan Tablets, USP. 160 mg. Rx only.,Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-
Recalled August 1, 2018 · FDA recall D-0967-2018 · MAJOR PHARMACEUTICALS
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
4,556 cartons
Sold at
Nationwide.
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
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.
Manufacturer(s)
MAJOR PHARMACEUTICALS
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →