Class II
Terminated
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
This recall has been terminated (originally issued September 1, 2021).
- Company
- Xellia Pharmaceuticals Usa, Llc
- Recall Initiated
- August 6, 2021
- Posted
- September 1, 2021
- Recall Number
- D-0756-2021
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 9,161 vials 50 mg and 100 mg vials total
- Firm Location
- Buffalo Grove, IL, United States
- Official Source
- View on FDA website ↗
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
Lot / Code Info
Lot 467111, exp 1/2023
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