# FDA recall D-0095-2017

> **Teva Pharmaceuticals USA** · Class III · drug recall initiated 2016-09-13.

## Product

mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA  92618, NDC 0703-4685-01.

## Reason for recall

Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-0095-2017
- **Recalling firm:** Teva Pharmaceuticals USA
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-09-13
- **Report date:** 2016-10-19
- **Termination date:** 2017-05-05

- **Voluntary/Mandated:** Voluntary: Firm initiated
- **Location:** North Wales, PA, United States

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0095-2017

## Citation

> AI Analytics. FDA recall D-0095-2017. Retrieved 2026-05-27 from https://api.ai-analytics.org/recall/D-0095-2017. Source: US FDA. Licensed CC0.

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