FDA-Drug2019-05-08Class II
Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
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.
Sold states
Nationwide USA and Puerto Rico
Affected count
164,424 bottles
Manufactured in
150 Allen Rd Ste 102, N/A, Basking Ridge, NJ, United States
Products
Losartan Potassium Tablets, USP, 50 mg, a) 90-count (NDC: 13668-409-90), b)1000-count (NDC: 13668-409-10) per bottle, Rx only, Manufactured by: Torrent Pharmaceuticals LTD, Indrad-382 721, Dist. Mehsana India
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1265-2019Don't want to check this manually?
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