Multi event Drug Recall Enforcement Report Class II voluntary initiated by Ascend Laboratories, LLC, originally initiated on 03-14-2023 for the product 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. The product was recalled due to cgmp deviations: detection of n-nitroso-dabigatran (ndab) impurity levels above the acceptable daily intake limit.. The product was distributed nationwide and the recall is currently ongoing.
Recall Enforcement Reports
| Recall Number |
Recall Initiation Date |
Report Date |
Recall Classification |
Quantity |
Product Description |
Recall Reason |
Status |
| D-0533-2023 | 03-14-2023 | 04-05-2023 | Class II | 13,560 bottles | 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. | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ongoing |
| D-0534-2023 | 03-14-2023 | 04-05-2023 | Class II | 12,804 bottles | Dabigatran Etexilate 150mg Capsules, 150 mg, Rx Only, 60 Capsules per bottle, Manufactured by: Alkem Laboratories Ltd., INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-475-60. | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. | Ongoing |
Recalled Products
| NDC |
Proprietary Name |
Non-Proprietary Name |
Dosage Form |
Route Name |
Company Name |
Product Type |
| 67877-474 | Dabigatran Etexilate | Dabigatran Etexilate | Capsule, Coated Pellets | Oral | Ascend Laboratories, Llc | Human Prescription Drug |
| 67877-475 | Dabigatran Etexilate | Dabigatran Etexilate | Capsule, Coated Pellets | Oral | Ascend Laboratories, Llc | Human Prescription Drug |
