MAJOR PHARMACEUTICALS recalls Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major P
Recalled July 17, 2019 · FDA recall D-1466-2019 · MAJOR PHARMACEUTICALS
Hazard
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer · FDA Class II
Units
3,102 Cartons (310,200 tablets)
Sold at
Nationwide.
Description
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level at the manufacturer
Product
Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
Manufacturer(s)
MAJOR PHARMACEUTICALS
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →