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FDAApril 30, 2019drug

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 recall recorded by the U.S. Food & Drug Administration.

The 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

What to do

FDA enforcement status: Terminated

Brands named

preferred pharmaceuticalspreferred

UPCs

6878800480368788004809

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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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 — Recall Details · AllClear