Class IIReported 2024-12-18
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
Recalled by Ascend Laboratories, LLC
Reason for Recall
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
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Recall NumberD-0129-2025ClassificationClass IIStatusOngoingCategorydrugInitiated2024-12-12Reported2024-12-18DistributionNationwide within the United StatesCode InfoLot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.