FDAFDA · Food and drugs·Recall number D-0533-2023
Dabigatran Etexilate Capsules, 75 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-474-60.
Published April 5, 2023 · Recall initiated: March 14, 2023
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: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DABIGATRAN ETEXILATE
- Manufacturer
- Ascend Laboratories, LLC
- Distributor
- Nationwide in the USA.
- UPC
- 0367877624600
- Lot
- Lot #s: 22142462, 22142463, 22142464, Exp 5/2024; 22143000, 22143001, 22143002, Exp 6/2024.
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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