XELLIA PHARMACEUTICALS USA, LLC recalls Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured fo
Recalled September 1, 2021 · FDA recall D-0756-2021 · XELLIA PHARMACEUTICALS USA
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. · FDA Class II
Units
9,161 vials 50 mg and 100 mg vials total
Sold at
Nationwide USA
Description
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.
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
Manufacturer(s)
XELLIA PHARMACEUTICALS USA, LLC
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →