FDAHealthDecember 12, 2024
Ascend Laboratories, LLC — Dabigatran Etexilate, 150mg capsules, 60-count bottles, Rx Only, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 070
⚠️ CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 12, 2024
Nationwide within the United States
What's affected?
- 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
- DABIGATRAN ETEXILATE
- Lot code
- 24142192
Additional details
Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 10,444 bottles.
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