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.

Recall Number: D-1451-2016

Firm: Teva North America

Classification: Class III

Status: Terminated

Report Date: 20160803

Initiation Date: 20160531

Termination Date: 20170508

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

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.