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.
Recall initiated: 20141203
Status: Terminated
Classification: Class I
Recall type: Voluntary: Firm initiated