# FDA recall D-1451-2016

> **Teva North America** · Class III · drug recall initiated 2016-05-31.

## Product

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

## Reason for recall

Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.

## Distribution

Nationwide

## Key facts

- **Recall number:** D-1451-2016
- **Recalling firm:** Teva North America
- **Classification:** Class III
- **Product type:** drug
- **Status:** Terminated
- **Initiation date:** 2016-05-31
- **Report date:** 2016-08-03
- **Termination date:** 2017-05-08

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

## Primary source

FDA Enforcement Reports: https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1451-2016

## Citation

> AI Analytics. FDA recall D-1451-2016. Retrieved 2026-06-02 from https://api.ai-analytics.org/recall/D-1451-2016. Source: US FDA. Licensed CC0.

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