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.
Recall initiated: 20230703
Status: Terminated
Classification: Class II
Recall type: Voluntary: Firm initiated