Class III · Low risk Terminated
mitoXANTRONE Injection USP
Reason Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
MitoXANTRONE Injection
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
What was recalled
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).
- Recalling firm
- Hospira Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0433-2015
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Mitoxantrone recalls
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Class III · Low risk Terminated
mitoXANTRONE Injection USP
Reason Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
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