FDA (Drugs) recall action 98452
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 Tablet/Capsule Specifications: Observed OOS results at 6-months long-term stability condition for Description test and Appearance by Visual Inspection test.
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.
Cipla USA is recalling three lots of Nilotinib Capsules 150 mg after out-of-specification results in description and visual appearance testing at six-month long-term stability.
Cipla USA is recalling one lot of Nilotinib Capsules 200 mg after out-of-specification results in description and visual appearance testing at six-month long-term stability.