FDA recall D-0756-2021

Product

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

Reason for recall

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.

Distribution

Nationwide USA

Key facts

Status

Terminated

Initiation date

2021-08-06

Report date

2021-09-01

Termination date

2024-09-29

Voluntary/Mandated

Voluntary: Firm initiated

Location

Buffalo Grove, IL, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0756-2021