FDAHealthDecember 12, 2024
Ascend Laboratories, LLC — Dabigatran Etexilate, 75 mg 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, 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
- Brand
- DABIGATRAN ETEXILATE
- Lot code
- 24142328
Additional details
Lot #: 24142328, 24142329, 24142330, Exp. Date May 31, 2026.
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 1971 bottles.
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