# FDA recall D-0757-2021

> **XELLIA PHARMACEUTICALS USA, LLC** · Class II · drug recall initiated 2021-08-06.

## 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

## 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.

## Distribution

Nationwide USA

## Key facts

- **Recall number:** D-0757-2021
- **Recalling firm:** XELLIA PHARMACEUTICALS USA, LLC
- **Classification:** Class II
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2021-08-06
- **Report date:** 2021-09-01
- **Termination date:** 2024-09-29

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Buffalo Grove, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0757-2021

## Citation

> AI Analytics. FDA recall D-0757-2021. Retrieved 2026-06-09 from https://api.ai-analytics.org/recall/D-0757-2021. Source: US FDA. Licensed CC0.

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