# FDA recall D-0918-2023

> **Accord Healthcare, Inc.** · Class II · drug recall initiated 2023-07-03.

## 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.

## Distribution

Nationwide within the United States

## Key facts

- **Recall number:** D-0918-2023
- **Recalling firm:** Accord Healthcare, Inc.
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2023-07-03
- **Report date:** 2023-07-19
- **Termination date:** 2024-10-17

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Durham, NC, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0918-2023

## Citation

> AI Analytics. FDA recall D-0918-2023. Retrieved 2026-06-24 from https://api.ai-analytics.org/recall/D-0918-2023. Source: US FDA. Licensed CC0.

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