MAJOR PHARMACEUTICALS recalls Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6
Recalled August 1, 2018 · FDA recall D-0966-2018 · MAJOR PHARMACEUTICALS
Hazard
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. · FDA Class II
Units
5,464 cartons
Sold at
Nationwide.
Description
CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product.
Product
Unit Dose Valsartan Tablets, USP, 80 mg. Rx only, Distributed by: Major Pharmaceuticals, Livonia, MI 48152, NDC# 0904-6594-61.
Manufacturer(s)
MAJOR PHARMACEUTICALS
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →