Torrent Pharma Inc. recalls Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking
Recalled October 9, 2019 · FDA recall D-0121-2020 · Torrent Pharma
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 9.82 parts per million. · FDA Class II
Units
8,688 bottles
Sold at
Nationwide USA and Puerto Rico
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 9.82 parts per million.
Product
Losartan Potassium Tablets, USP 50mg, 1000 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-409-10
Manufacturer(s)
Torrent Pharma Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →