Torrent Pharma Inc. recalls Losartan Potassium /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Tor
Recalled October 9, 2019 · FDA recall D-0123-2020 · 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
17,088 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 /Hydrochlorothiazide Tablets, USP 50mg/12.5mg, 90 tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-116-90
Manufacturer(s)
Torrent Pharma Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →