WhichRecall
Class IIReported 2024-12-18

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

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 Number
D-0130-2025
Classification
Class II
Status
Ongoing
Category
drug
Initiated
2024-12-12
Reported
2024-12-18
Distribution
Nationwide within the United States
Code Info
Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;
Source: openFDA enforcement report. WhichRecall is not affiliated with the FDA. See our disclaimer.
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