Class IIReported 2025-07-23
Rizatriptan Benzoate Tablets, USP, 5 mg, 18 (3x6) Unit Dose Tablets, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories LLC, Parsippany, NJ 07054, NDC 67877-261-18
Recalled by Ascend Laboratories, LLC
Reason for Recall
CGMP Deviations: detection of N-nitroso-dimethyl-rizatriptan impurity, above the FDA recommended acceptable intake limit.
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Recall NumberD-0533-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2025-07-09Reported2025-07-23DistributionUS Nationwide.Code InfoLot 23142117, 23142119, 23142122, Exp Date: May 2026; Lot 24142625, Exp Date: Jun. 2027Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.