FDA (Drugs) recall action 97438
The FDA (Drugs) publishes a recall like this one as 5 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 5 pages.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging 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.
Amneal chlorpromazine hydrochloride tablets, 50 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.
Amneal sulfamethoxazole and trimethoprim double strength tablets are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.
Amneal chlorpromazine hydrochloride tablets, 25 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.
Amneal chlorpromazine hydrochloride tablets, 100 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.
Amneal chlorpromazine hydrochloride tablets, 200 mg, are recalled because a micro-organism was detected on a lot of auxiliary polyester coil used in packaging. No micro-organism was found on any tablets.