Buffalo Grove, IL, United States
XELLIA PHARMACEUTICALS USA, LLC recalls
1 recall recorded since 2018, most recently on 6 August 2021. None are listed as ongoing. Status and classification are as published by the FDA.
Recalls1
Ongoing (FDA)0
Terminated or completed1
Class I (FDA)0
Terminated Class II Drugs
- Recall started
- 6 August 2021
- Terminated
- 29 September 2024
- Reason
- 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.
- Distribution
- Nationwide USA
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0757-2021, D-0756-2021
- 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
- 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
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.