FDA (Drugs) recall action 67412
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.
CGMP Deviations: Ethambutol Hydrochloride Tablets, USP, 400 mg were manufactured using unapproved material: the incorrect gelatin excipient than specified in the product formulation.
CGMP Deviations: Dextroamphetamine Saccharate, Amphetamine Asparate, Dextroamphetamine Sulfate and Amphetamine Sulfate Tablets, CII, 10 mg were manufactured using unapproved material: the finished product was not properly quarantined as rejected due to inadequate cleaning of equipment.
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
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.
Teva Pharmaceuticals is recalling specific lots of Ethambutol Hydrochloride Tablets because they were manufactured with an unapproved gelatin excipient.
Teva Pharmaceuticals is recalling specific lots of Dextroamphetamine tablets because they were manufactured using unapproved material and not properly quarantined.
Teva Pharmaceuticals is recalling specific lots of Hydroxyzine Pamoate capsules because they were manufactured using an unapproved active pharmaceutical ingredient.
Teva Pharmaceuticals USA is recalling 2,494 bottles of Hydroxyzine Pamoate Capsules, 100 mg, because the active ingredient was incorrectly released for use.