Micafungin for Injection recalled for incomplete package insert
Xellia Pharmaceuticals is recalling Micafungin for Injection 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 deficiencies. The source text does not report any illnesses, injuries, or hospitalizations; the hazard is a missing-information issue rather than product contamination or physical defect. This is a moderate labeling error affecting medication safety information.
Plain-English summary
Xellia Pharmaceuticals USA, LLC is recalling Micafungin for Injection, 100 mg/vial, Single-Dose Vial (NDC 70594-037-01, Lot 467111, expiration 1/2023) nationwide in the United States. The package insert provided with the product does not include all required sections that have been approved for this drug.
Specifically, the labeling is missing required information on adverse reactions, drug interactions, and use in specific populations. These omissions prevent healthcare providers and patients from receiving complete safety and usage information necessary for proper administration of this intravenous injection.
Micafungin is a prescription antifungal medication. The incomplete labeling affects 9,161 units of 50 mg and 100 mg vials in total. Patients and healthcare providers who have this product should contact their pharmacy or healthcare provider for the corrected package insert and guidance on appropriate use of the medication.
The recalled product
- Product
- 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
- Manufacturer
- XELLIA PHARMACEUTICALS USA, LLC
- Hazard
- missing-labeling
- incomplete-package-insert
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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