FDA Drug recall D-0918-2023
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc
- FDA Drug
- Class II
- terminated
- Published 2023-07-19
On 2023-07-19 the FDA classified a Class II recall of Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc by Accord Healthcare, citing presence of Particulate Matter: Particulate matter identified as fiber.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0918-2023 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2023-07-03 |
| Published | 2023-07-19 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Accord Healthcare |
| Distribution | US |
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
Presence of Particulate Matter: Particulate matter identified as fiber.
Identifiers
| ndc | 16729-275-03 |
|---|---|
| ndc | 16729-275-67 |
| code_info | Lot #: M2212070 Exp. date 08/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0918-2023%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.