Bivalirudin for Injection 250 mg recall: Particulate Matter
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas…
Why was Bivalirudin for Injection 250 mg recalled?
Presence of Particulate Matter: Particulate matter identified as fiber.
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: M2212070 Exp. date 08/2024
- Product
- Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC 27703 Manufactured by: Intas…
- Recalling firm
- Accord Healthcare, Inc.
- Quantity
- 1680 vials
- Distribution
- Nationwide within the United States
- Recall date
- July 19, 2023
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)