FDA-Drug2020-10-07Class II
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
Direct Rx
Hazard
CGMP deviation: Trace amounts of impurity detected to be N-Methylnitrosobutyric acid (NMBA) in the API.
Sold states
FL
Affected count
33 bottles
Manufactured in
94 Worldwide Dr, N/A, Dawsonville, GA, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0032-2021Don't want to check this manually?
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