FDA (Drugs) recall action 84797
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.
CGMP deviations: Product bottle may be absent of desiccant.
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 USA is recalling 17,436 bottles of Methylphenidate Hydrochloride Extended-Release tablets because the product bottles may be missing desiccant.
Teva Pharmaceuticals is recalling specific bottles of Methylphenidate Hydrochloride Extended-Release tablets because they may be missing the desiccant packet.