FDAFDA · Food and drugs·Recall number D-0918-2023
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.
Published July 19, 2023 · Recall initiated: July 3, 2023
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Presence of Particulate Matter: Particulate matter identified as fiber.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- BIVALIRUDIN
- Manufacturer
- Accord Healthcare, Inc.
- Distributor
- Nationwide within the United States
- UPC
- 0316729275033
- Lot
- Lot #: M2212070 Exp. date 08/2024
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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