Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Bivalirudin for Injection 250 mg Recalled by Accord Healthcare, Inc. Due to Presence of Particulate Matter: Particulate matter identified as...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Accord Healthcare, Inc. directly.
Affected Products
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.
Quantity: 1680 vials
Why Was This Recalled?
Presence of Particulate Matter: Particulate matter identified as fiber.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Accord Healthcare, Inc.
Accord Healthcare, Inc. has 76 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report