XELLIA PHARMACEUTICALS USA, LLC: Drug Recall

Recall #D-0757-2021 · 08/06/2021

Class II: Risk

Recall Details

Recall Number: D-0757-2021
Classification: Class II
Product Type: Drug
Recalling Firm: XELLIA PHARMACEUTICALS USA, LLC
Status: Terminated
Date Initiated: 08/06/2021
Location: Buffalo Grove, IL, United States
Voluntary/Mandated: Voluntary: Firm initiated
Product Quantity: 9,161 (50mg and 100 mg vials total)

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.

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

Distribution Pattern

Nationwide USA

Other Recalls by XELLIA PHARMACEUTICALS USA, LLC

Class II: Risk 08/06/2021

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.

View all recalls by XELLIA PHARMACEUTICALS USA, LLC →

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.