Micafungin for Injection Recalled for Incomplete Package Insert
Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class II recall involving labeling deficiency—specifically a missing or incomplete package insert. No illnesses, injuries, or deaths are reported. The hazard is informational and precautionary rather than direct product contamination or instability.
Plain-English summary
Xellia Pharmaceuticals USA, LLC is recalling Micafungin for Injection, 50 mg/vial, Single-Dose Vial (NDC 70594-036-01, Lot 467111, expiration 1/2023) nationwide. A total of 9,161 vials of 50 mg and 100 mg are affected.
The package insert provided with the product does not include all required sections approved for this product. Specifically, the insert is missing required information on Adverse Reactions, Drug Interactions, and Use in Specific Populations.
Healthcare providers and patients should not use vials from the affected lot. Contact Xellia Pharmaceuticals USA, LLC for replacement product or further instructions.
The recalled product
- 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
- XELLIA PHARMACEUTICALS USA, LLC
- Category
- Drug — Injectable / Antifungal
- Hazard
- labeling-deficiency
- incomplete-package-insert
- missing-safety-information
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot 467111
- exp 1/2023
Distribution
Distributed nationwide across the United States.
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