Reported Jul 19, 2023 · Terminated
Bivalirudin for Injection 250 mg, 10 Single-Dose Vials, Rx Only, Manufactured for: Accord Healthcare, Inc. Durham, NC…
Accord Healthcare, Inc.
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: Accord Healthcare, Inc. · 1009 Slater Rd Ste 210B · Durham, NC · 27703-8446
Is this the product you have?
Bivalirudin for Injection 250 mg10 Single-Dose VialsRx Only
- Manufactured forAccord Healthcare, Inc. Durham
- NC 27703 Manufactured byIntas Pharmaceuticals Limited Ahmedabad-382 210, India, NDC 16729-275-67
- Lot codes and dates
- Lot #: M2212070 Exp. date 08/2024
- Amount recalled
- 1680 vials
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Presence of Particulate Matter: Particulate matter identified as fiber.
This product could cause temporary or reversible health problems — stop using it.
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The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.
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