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
Recall initiated: 20241212
Status: Ongoing
Classification: Class II
Recall type: Voluntary: Firm initiated