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FDARecalled Jul 19, 2023 · #D-0918-2023

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, ...

Hazard

Class II — temporary health risk

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Description

Presence of Particulate Matter: Particulate matter identified as fiber. Classification: Class II Distribution: Nationwide within the United States

Product details

Product
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.
Type
Drugs
Manufacturer
Accord Healthcare, Inc.
Model numbers
M2212070
UPCs