Reported Sep 1, 2021 · Terminated
Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only, Manufactured…
Xellia Pharmaceuticals USA, LLC
Moderate riskThis product could cause temporary or reversible health problems — stop using it.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: XELLIA PHARMACEUTICALS USA, LLC · 2150 E Lake Cook Rd · Buffalo Grove, IL · 60089-1862
Is this the product you have?
- Micafungin for Injection, 100 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusion Only
- Manufactured forXellia Pharmaceuticals USA, LLC, Buffalo Grove, IL 60089. NDC 70594-037-01
- Lot codes and dates
Lot 467111exp 1/2023
- Amount recalled
- 9,161 (50mg and 100 mg vials total)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
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.
This product could cause temporary or reversible health problems — stop using it.
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