FDA (Drugs) recall action 72234
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: The active pharmaceutical ingredient (API) intended for use in furosemide oral solution USP was inadvertently used to manufacture the recalled furosemide tablets USP.
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.
Boehringer Ingelheim Roxane Inc. is recalling furosemide tablets USP because the wrong active pharmaceutical ingredient was used during manufacturing.
Boehringer Ingelheim Roxane Inc. is recalling 5,160 bottles of Furosemide Tablets USP because the wrong active ingredient was used during manufacturing.