Why it was recalled
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0130-2025
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 12, 2024
- FDA report date
- Dec 18, 2024
- Quantity
- 10,444 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Ascend Laboratories, LLC
Original FDA data
Every field from FDA enforcement report D-0130-2025, exactly as published.
Show all FDA fields
- City
- Parsippany
- State
- NJ
- Status
- Ongoing
- Country
- United States
- Event ID
- 95896
- Address
- 339 Jefferson Rd Ste 101
- Code information
- Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;
- Postal code
- 07054-3707
- Report date
- Dec 18, 2024
- Product type
- Drugs
- Recall number
- D-0130-2025
- Classification
- Class II
- Recalling firm
- Ascend Laboratories, LLC
- Product quantity
- 10,444 bottles
- Reason for recall
- CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Dec 12, 2024
- Initial firm notification
- Letter
- Center classification date
- Dec 12, 2024