FDA (Drugs) recall action 83840
The FDA (Drugs) publishes a recall like this one as 4 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 4 pages.
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.
The agency’s own wording, quoted from the enforcement report.
The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.
Torrent Pharma Inc. is recalling Losartan Potassium Tablets 100 mg because FDA testing found an impurity above acceptable levels.
Torrent Pharma Inc. is recalling Losartan Potassium Tablets 50mg because FDA testing found an impurity above acceptable levels.
Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide Tablets because FDA testing found an impurity above acceptable levels.
Torrent Pharma Inc. is recalling Losartan Potassium/Hydrochlorothiazide tablets due to the presence of an impurity above acceptable levels.