FDAFDA · Food and drugs·Recall number D-0756-2021
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
Published September 1, 2021 · Recall initiated: August 6, 2021
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the 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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- XELLIA PHARMACEUTICALS USA, LLC
- Distributor
- Nationwide USA
- Lot
- Lot 467111, exp 1/2023
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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