# FDA recall D-0433-2015

> **Hospira Inc.** · Class I · drug recall initiated 2014-12-03.

## Product

MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only.  Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).

## Reason for recall

Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.

## Distribution

US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.

## Key facts

- **Recall number:** D-0433-2015
- **Recalling firm:** Hospira Inc.
- **Classification:** Class I
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2014-12-03
- **Report date:** 2015-04-15
- **Termination date:** 2016-12-02

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** Lake Forest, IL, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0433-2015

## Citation

> AI Analytics. FDA recall D-0433-2015. Retrieved 2026-05-28 from https://api.ai-analytics.org/recall/D-0433-2015. Source: US FDA. Licensed CC0.

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