Dabigatran Etexilate 150mg Capsules — Class II drug recall D-0534-2023
Ongoing recall by Ascend Laboratories, LLC, reported 2023-04-05, distributed nationwide. CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Li
| Recall number | D-0534-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Ascend Laboratories, LLC, Parsippany, NJ, United States |
| Recall initiated | 2023-03-14 |
| Classified | 2023-04-13 |
| Reported by FDA | 2023-04-05 |
| Distributed | Nationwide (US) |
| Quantity | 12,804 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 67877-0474, 67877-0474-60, 67877-0475, 67877-0475-60, 67877-0624, 67877-0624-31, 67877-0624-60 |
| Lot numbers | 22142448, 22142449, 22142450, 22143845 |
| Expiration dates | 2024-05, 2024-07 |
Product
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.
Reason for recall
CGMP Deviations: Detection of N-nitroso-dabigatran (NDAB) impurity levels above the Acceptable Daily Intake Limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0534-2023. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.