D-0130-2025 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- December 18, 2024
- Initiation Date
- December 12, 2024
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,444 bottles
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
Reason for Recall
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Distribution Pattern
Nationwide within the United States
Code Information
Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;