FDARecalled Dec 18, 2024 · #D-0129-2025
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
Hazard
Class II — temporary health risk
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CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit Classification: Class II Distribution: Nationwide within the United States
Product details
- 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
- Type
- Drugs
- Manufacturer
- Ascend Laboratories, LLC
- Model numbers
- 24142328
- UPCs
- —