Ascend Laboratories, LLC: Drug Recall
Recall #D-0130-2025 · 12/12/2024
Class II: Risk
Recall Details
- Recall Number
- D-0130-2025
- Classification
- Class II
- Product Type
- Drug
- Recalling Firm
- Ascend Laboratories, LLC
- Status
- Ongoing
- Date Initiated
- 12/12/2024
- Location
- Parsippany, NJ, United States
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,444 bottles
Reason for Recall
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
Distribution Pattern
Nationwide within the United States
Other Recalls by Ascend Laboratories, LLC
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 09/19/2025
- Class II: Risk 08/28/2025
Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.