FDA-Drug2019-10-09Class II
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
Torrent Pharma Inc.
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.
Sold states
Nationwide USA and Puerto Rico
Affected count
39,432 bottles
Manufactured in
150 Allen Rd Ste 102, N/A, Basking Ridge, NJ, United States
Products
Losartan Potassium Tablets, USP 100 mg, [90 or 1000] tablets per bottle, Rx Only, Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC 90 tablets: 13668-115-90; NDC 1000 tablets: 13668-115-10
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0122-2020Don't want to check this manually?
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