FDA-Drug2021-09-01Class II
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
XELLIA PHARMACEUTICALS USA, LLC
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.
Sold states
Nationwide USA
Affected count
9,161 vials 50 mg and 100 mg vials total
Manufactured in
2150 E Lake Cook Rd, N/A, Buffalo Grove, IL, United States
Products
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 notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0756-2021Don't want to check this manually?
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