Class II
Ongoing
Dabigatran Etexilate, 75 mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-474-60
This recall is currently active, issued December 18, 2024. It was issued by Ascend Laboratories, Llc.
- Company
- Ascend Laboratories, Llc
- Recall Initiated
- December 12, 2024
- Posted
- December 18, 2024
- Recall Number
- D-0129-2025
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1971 bottles
- Firm Location
- Parsippany, NJ, United States
- Official Source
- View on FDA website ↗
Reason for Recall
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.
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