Drug recall D-0918-2023

Class II Terminated reported Jul 19, 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.

Reason for recall

Presence of Particulate Matter: Particulate matter identified as fiber.

Lots and codes

Lot #: M2212070 Exp. date 08/2024

Recall details

Recalling firm
Accord Healthcare, Inc., Durham, NC
Quantity
1680 vials
Distribution
Nationwide within the United States
Type
Voluntary: Firm initiated
Recall initiated
July 3, 2023
Terminated
October 17, 2024

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