FDA (Drugs) recall action 65515
The FDA (Drugs) publishes a recall like this one as 3 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 3 pages.
Failed Dissolution Specifications: Product is being recalled due to out of specification dissolution results obtained during routine stability testing.
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 7,579 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.
Teva Pharmaceuticals is recalling 16,293 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.
Teva Pharmaceuticals is recalling 13,478 bottles of Methylphenidate Hydrochloride Extended-Release Capsules because routine stability testing revealed out-of-specification dissolution results.