The Recall Desk

FDA (Drugs) recall action 88457

XELLIA PHARMACEUTICALS USA, LLC recalled 2 products on 2021-09-01

The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.

Products
2
Announced
2021-09-01
Critical
0
Units
—

Why these products were 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.

The agency’s own wording, quoted from the enforcement report.

1–2 of 2

  • ModerateFDA (Drugs)··2021-09-01

    Micafungin for Injection Recalled for Incomplete Package Insert

    Xellia Pharmaceuticals USA is recalling Micafungin for Injection 50 mg/vial due to an incomplete package insert that omits required sections on Adverse Reactions, Drug Interactions, and Use in Specific Populations.

    Product
    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
    Category
    Distribution
    0 states
  • ModerateFDA (Drugs)··2021-09-01

    Micafungin for Injection recalled for incomplete package insert

    Xellia Pharmaceuticals is recalling Micafungin for Injection due to an incomplete package insert that omits required sections on adverse reactions, drug interactions, and use in specific populations.

    Product
    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
    Category
    Distribution
    0 states