FDA (Drugs) recall action 79955
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
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.
Mylan Pharmaceuticals is recalling 8,679 bottles of Loxapine Capsules 25 mg due to CGMP deviations. The product was distributed throughout the United States and Puerto Rico.
Mylan Pharmaceuticals is voluntarily recalling 11,650 bottles of Loxapine Capsules 50 mg due to Current Good Manufacturing Practice (CGMP) deviations.