Class II
Terminated
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.
- Company
- Accord Healthcare, Inc.
- Recall Initiated
- July 3, 2023
- Posted
- July 19, 2023
- Recall Number
- D-0918-2023
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 1680 vials
- Firm Location
- Durham, NC, United States
Reason for Recall
Presence of Particulate Matter: Particulate matter identified as fiber.
Distribution
Nationwide within the United States
Lot / Code Info
Lot #: M2212070 Exp. date 08/2024
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