Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Reason CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Reason CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
Reason CGMP Deviations: N-Nitroso Desmethyl Rizatriptan Impurity results that are above the FDA acceptable limit.
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