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.

Recall Number: D-0095-2017

Firm: Teva Pharmaceuticals USA

Classification: Class III

Status: Terminated

Report Date: 20161019

Initiation Date: 20160913

Termination Date: 20170505

Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.

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.