US Drug Recall Register
Class II · Moderate risk Terminated Initiated Aug 6, 2021 (5 years ago)

Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For…

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

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.

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

Recalling firm
Xellia Pharmaceuticals USA, LLC
NDC code
70594-037-01
Origin
IL, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0757-2021

What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.

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