FDA (Drugs) recall action 97523
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.
Presence of a Foreign Substance: A specific lot of auxiliary polyester coil, used in product packaging by manufacturer (Amneal Pharmaceuticals LLC) was detected with presence of a micro-organism. No micro-organism was detected on any tablets.
The agency’s own wording, quoted from the enforcement report.
Sulfamethoxazole and Trimethoprim double strength tablets distributed by Cardinal Health are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected on any tablets.
Sulfamethoxazole and Trimethoprim double strength unit dose cartons from Major Pharmaceuticals are recalled because a micro-organism was found on a lot of packaging coil. No micro-organism was detected on any tablets.