FDA-Drug2019-05-22Class II
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
Preferred Pharmaceuticals, 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 at the manufacturer
Sold states
CA, GA, IN. No DOD/VA accounts. No foreign accounts.
Manufactured in
1250 N Lakeview Ave Ste O, Anaheim, CA, United States
Products
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1281-2019Don't want to check this manually?
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