D-0757-2021 Class II Terminated
Recall Details
- Product Type
- Drugs
- Report Date
- September 1, 2021
- Initiation Date
- August 6, 2021
- Termination Date
- September 29, 2024
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 9,161 (50mg and 100 mg vials total)
Product Description
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
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 Pattern
Nationwide USA
Code Information
Lot 467111, exp 1/2023