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Micafungin for Injection, 50 mg/vial, Single-Dose Vial, Sterile, Rx Only, For Intravenous Infusio...

FDA Recall #D-0756-2021 — Class II — August 6, 2021

Recall #D-0756-2021 Date: August 6, 2021 Classification: Class II Status: Terminated

Product Description

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

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.

Recalling Firm

XELLIA PHARMACEUTICALS USA, LLC — Buffalo Grove, IL

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

9,161 vials 50 mg and 100 mg vials total

Distribution

Nationwide USA

Code Information

Lot 467111, exp 1/2023

Status

Terminated

Voluntary / Mandated

Voluntary: Firm initiated

What Should You Do?

Stop using this medication immediately and contact your pharmacist or doctor. Do not flush medications down the drain. Return the product to the place of purchase for a refund or replacement.

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