Drug recall D-0130-2025
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
Lots and codes
Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;
Recall details
- Recalling firm
- Ascend Laboratories, LLC, Parsippany, NJ
- Quantity
- 10,444 bottles
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 12, 2024
Related products
- Dabigatran Etexilate – drug information
- NDC 67877-475 Dabigatran Etexilate · Dabigatran Etexilate Mesylate 150 mg/1 · Ascend Laboratories, LLC
- NDC 67877-624 Dabigatran Etexilate · Dabigatran Etexilate Mesylate 110 mg/1 · Ascend Laboratories, LLC
- NDC 67877-474 Dabigatran Etexilate · Dabigatran Etexilate Mesylate 75 mg/1 · Ascend Laboratories, LLC