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.
Recall initiated: 20160913
Status: Terminated
Classification: Class III
Recall type: Voluntary: Firm initiated