Recalls / Class II
Class IID-0918-2023
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.
- Brand name
- Bivalirudin
- Generic name
- Bivalirudin
- Active ingredient
- Bivalirudin
- Route
- Intravenous
- NDC
- 16729-275
- FDA application
- ANDA206551
- Affected lot / code info
- Lot #: M2212070 Exp. date 08/2024
Why it was recalled
Presence of Particulate Matter: Particulate matter identified as fiber.
Recalling firm
- Firm
- Accord Healthcare, Inc.
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 1009 Slater Rd Ste 210B, N/A, Durham, North Carolina 27703-8446
Distribution
- Quantity
- 1680 vials
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2023-07-03
- FDA classified
- 2023-07-13
- Posted by FDA
- 2023-07-19
- Terminated
- 2024-10-17
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-0918-2023. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.