Bivalirudin for Injection 250 mg — Class II drug recall D-0918-2023
Terminated recall by Accord Healthcare, Inc., reported 2023-07-19, distributed nationwide. Presence of Particulate Matter: Particulate matter identified as fiber.
| Recall number | D-0918-2023 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Accord Healthcare, Inc., Durham, NC, United States |
| Recall initiated | 2023-07-03 |
| Classified | 2023-07-13 |
| Reported by FDA | 2023-07-19 |
| Terminated | 2024-10-17 |
| Distributed | Nationwide (US) |
| Quantity | 1,680 vials |
| Reason classes | specification failure |
| NDC | 16729-0275, 16729-0275-03, 16729-0275-67 |
| Lot numbers | M2212070 |
| Expiration dates | 2024-08 |
Product
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67.
Reason for recall
Presence of Particulate Matter: Particulate matter identified as fiber.
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-0918-2023. 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.