FDA (Drugs) recall action 97533
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.
Presence of a foreign substance.A specific lot of auxiliary polyester coil, used in product packaging at the manufacturing site, 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.
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.
Chlorpromazine Hydrochloride Tablets, USP, 200 mg, in blister cartons from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 873 cartons are affected.
Chlorpromazine Hydrochloride Tablets, USP, 25 mg, in blisterpacks from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 2,708 cartons are affected.
Chlorpromazine Hydrochloride Tablets, USP, 50 mg, in blisterpacks from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,062 cartons are affected.
Chlorpromazine Hydrochloride Tablets, USP, 100 mg, in blisterpack cartons from American Health Packaging, are recalled because a micro-organism was found on a lot of packaging coil. 1,757 cartons are affected.