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FDAAugust 6, 2021drug

Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-036-01

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

Labeling; Incorrect or Missing Package Insert: The package insert provided with the product does not include all required sections approved for this product. This includes aspects of Adverse Reactions, Drug Interactions and Use in Specific Populations.

What to do

FDA enforcement status: Terminated

Brands named

xellia pharmaceuticalsxellia

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

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