Accord Healthcare recalls 10 vials of Bivalirudin 250mg injection due to fiber particles. This may cause serious injury if injected. Stop using and contact for return.
Presence of Particulate Matter: Particulate matter identified as fiber.
Accord Healthcare is recalling 10 vials of Bivalirudin 250mg injection because they contain fiber particles. This could cause serious injury if the product is injected.
The injection vials contain fiber particles that could cause serious injury if injected into the body. This is a known risk with particulate matter in injectable drugs.
People who have the 10 vial package of Bivalirudin 250mg injection for medical use. Those with the specific lot number M2212070 are most at risk.
Check for the product name Bivalirudin 250mg injection, 10 single-dose vials, manufactured by Accord Healthcare. The lot number M2212070 is part of the affected batch.
Discard the vials immediately if you have the affected lot number M2212070.
No, the product contains fiber particles that could cause serious injury if injected.
Check for the lot number M2212070 on the vial packaging.
Discard the vials immediately and contact Accord Healthcare for a replacement.
We’ve drafted a message you can send Accord Healthcare to request your refund or repair — edit it as you like.
Subject: Recall D-0918-2023 — Accord Healthcare Accord Healthcare Hello, I own a Accord Healthcare that is covered by recall D-0918-2023 from Accord Healthcare. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
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The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
