FDA recall D-0095-2017

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.

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-09-13

Report date

2016-10-19

Termination date

2017-05-05

Voluntary/Mandated

Voluntary: Firm initiated

Location

North Wales, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0095-2017