Recall D-0130-2025

US Class II Ongoing · initiated 2024-12-12

Recalling firm

Ascend Laboratories, LLC, NJ

Product

Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-475-60

Reason for recall

CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit

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