DABIGATRAN ETEXILATE
Wed Dec 18 2024
1 of 9
Summary
CGMP Deviations: Presence of N-nitroso-Dabigatran impurity above recommended interim limit
Product Description
| Drug | Manufacturer | Distribution Pattern | Number of Affected Units |
|---|---|---|---|
| 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 | Ascend Laboratories, LLC | Nationwide within the United States | |
| 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 | Ascend Laboratories, LLC | Nationwide within the United States | 12,092 bottles |