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
Reported: September 1, 2021 Initiated: August 6, 2021 #D-0757-2021
Product Description
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
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.
Details
- Recalling Firm
- XELLIA PHARMACEUTICALS USA, LLC
- Units Affected
- 9,161 (50mg and 100 mg vials total)
- Distribution
- Nationwide USA
- Location
- Buffalo Grove, IL
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by XELLIA PHARMACEUTICALS USA, LLC. Units affected: 9,161 (50mg and 100 mg vials total).
Why was this product 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.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on September 1, 2021. Severity: Moderate. Recall number: D-0757-2021.
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