Recalls / Class II
Class IID-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
- Brand name
- Dabigatran Etexilate
- Generic name
- Dabigatran Etexilate
- Active ingredient
- Dabigatran Etexilate Mesylate
- Route
- Oral
- NDCs
- 67877-474, 67877-475, 67877-624
- FDA application
- ANDA208040
- Affected lot / code info
- Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;
Why it was recalled
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Recalling firm
- Firm
- Ascend Laboratories, LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 339 Jefferson Rd Ste 101, Parsippany, New Jersey 07054-3707
Distribution
- Quantity
- 10,444 bottles
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2024-12-12
- FDA classified
- 2024-12-12
- Posted by FDA
- 2024-12-18
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0130-2025. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.