FDAFDA · Food and drugs·Recall number D-0130-2025
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
Published December 18, 2024 · Recall initiated: December 12, 2024
Status when published: Ongoing — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- Nationwide within the United States
- UPC
- 0367877624600
- Lot
- Lot #: 24142192, 24142193, 24142194, Exp. Date April 30, 2026; 24142463, Exp. Date May 31, 2026;
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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