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Class II · ModerateRecall completed

Bivalirudin

Could cause temporary or reversible harm; serious harm is unlikely.

Does this affect you?
Check your lot numberLot #: M2212070 Exp. date 08/2024
Where it was soldNationwide within the United States
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of Particulate Matter: Particulate matter identified as fiber.

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byIntas Pharmaceuticals Limited Ahmedabad-382 210, India foreign manufacturer
Brand nameBIVALIRUDIN
Generic nameBIVALIRUDIN
Active ingredient(s)BIVALIRUDIN
Distributed by / forAccord Healthcare, Inc. Durham, NC 27703
NDC16729-275-67
Show the full FDA record
Full product labelBivalirudin 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.
Recalling firmAccord Healthcare, Inc.
DistributionNationwide within the United States
Quantity1680 vials
Recall initiated2023-07-03
Report date2023-07-19
Recall completed2024-10-17
Recall numberD-0918-2023
ClassificationClass II
FDA statusTerminated
Origin on fileDurham NC United States

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Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.