Preferred Pharmaceuticals, Inc recalls Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09)
Recalled March 27, 2019 · FDA recall D-1051-2019 · Preferred Pharmaceuticals
Hazard
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified. · FDA Class II
Units
530
Sold at
California, Georgia, Indiana
Description
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified.
Product
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottle (NDC: 68788-0048-03), b) 90-count bottle (NDC: 68788-0048-09), Rx Only, Mfg: Torrent Pharma Inc. Basking Ridge, NJ. Relabeled by: Preferred Pharmaceuticals, Inc. 1250 N. Lakeview Ave., Suite O, Anaheim, CA 92807.
Manufacturer(s)
Preferred Pharmaceuticals, Inc
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →