AVKARE Inc. recalls Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc.
Recalled May 8, 2019 · FDA recall D-1249-2019 · AVKARE
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 of 0.96 parts per million. · FDA Class II
Units
1438 cartons (71,900 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 of 0.96 parts per million.
Product
Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC 50268-517-15 Manufactured for: AvKARE Inc. Pulaski, TN 38478
Manufacturer(s)
AVKARE Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →