FDA (Drugs) recall action 85307
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.
Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
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.
Avet Pharmaceuticals is recalling Tetracycline Hydrochloride capsules due to out-of-specification dissolution results found during long-term testing.
Avet Pharmaceuticals is recalling 17,524 bottles of Tetracycline Hydrochloride 500 mg capsules because they failed dissolution specifications during long-term testing.