XELLIA PHARMACEUTICALS USA, LLC recalls Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured…

Recall date

August 6, 2021

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0757-2021

FDA classification

Class II

Brand / firm

XELLIA PHARMACEUTICALS USA, LLC

Sold / distributed

Nationwide USA

Why it was recalled

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.

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured for: Xellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01