Direct Rx recalls Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharm
Recalled October 7, 2020 · FDA recall D-0032-2021 · Direct Rx
Hazard
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API. · FDA Class II
Units
33 bottles
Sold at
FL
Description
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Product
Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
Manufacturer(s)
Direct Rx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →