FDA (Drugs) recall action 96983
The FDA (Drugs) publishes a recall like this one as 2 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 2 pages.
CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.
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 Fluoxetine Tablets USP 20 mg due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit. The affected lot is distributed nationwide.
Torrent Pharma Inc. is recalling Fluoxetine Tablets, USP, 20 mg in a 28-count carton due to the presence of N-Nitroso Fluoxetine exceeding the interim acceptable intake limit.