Drug 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
D-0130-2025
Product summary
- Event
- Event 95896
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,444 bottles
- Official record key
drug-enforcement:D-0130-2025
Official wording
Reason: CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Code information: Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Foreign material or chemical contamination
N-nitroso-Dabigatran impurity
-
Manufacturing or process control
CGMP Deviations