FDA (Drugs) recall action 88872
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.
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
The agency’s own wording, quoted from the enforcement report.
MacLeods Pharma USA is recalling Rizatriptan Benzoate Film Coated Tablets (10 mg) due to out-of-specification test results in organic impurities testing. The recall affects multiple lot numbers distributed nationwide.
Macleods Pharma USA is recalling Rizatriptan Benzoate 10mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing of controlled samples.
Macleods Pharma USA is recalling Rizatriptan Benzoate 5mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing. The affected lots are BRL2102A and BRL2103A with expiration date 04/2025.