DABIGATRAN ETEXILATE MESYLATE Recall D-0534-2023
Description: 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.
DABIGATRAN ETEXILATE MESYLATE Recall D-0534-2023 Information
| Status | Ongoing |
| Mandated? | Voluntary: Firm initiated |
| Recall Number | D-0534-2023 |
| Event ID | 91880 |
| Brand | DABIGATRAN ETEXILATE |
| Generic Name | DABIGATRAN ETEXILATE |
| Manufacturer | DABIGATRAN ETEXILATE |
| Original Package? | 1 |
| Active Substance | DABIGATRAN ETEXILATE MESYLATE |
| Drug Route | ORAL |
| Distribution | Nationwide in the USA. |
| Quantity | 12,804 bottles |
| Recall Reason | CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit. |
| Drug Classification | Class II |
| Drug Code Info | 20230405 |
| Product NDC | 67877-474 67877-475 |
| Drug UPC | 0367877474601 |
| Recall Initiation Date | 20230314 |
| Report Date | 20230405 |
| Classification Date | 20230413 |
| Address | 339 Jefferson Rd Ste 101 Parsippany, NJ 07054-3707 United States |
| Recalling Firm | Ascend Laboratories, LLC |
| Initial Notification | Letter |
| Unique Ingredient Identifier | SC7NUW5IIT |
| Drug Application Number | ANDA208040 |
| Structured Product Labeling (SPL ID) | 275af0ce-a28d-4da9-889c-2d6c8c3841df |
| Structured Product Labeling (SPL Set ID) | 3a8ec82a-c367-40dc-9302-e1896fcb05ea |
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