Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthc...
FDA Recall #D-0918-2023 — Class II — July 3, 2023
Product Description
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.
Recalling Firm
Accord Healthcare, Inc. — Durham, NC
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
1680 vials
Distribution
Nationwide within the United States
Code Information
Lot #: M2212070 Exp. date 08/2024
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated