FDA recall D-1451-2016

Product

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.

Reason for recall

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

Distribution

Nationwide

Key facts

Status

Terminated

Initiation date

2016-05-31

Report date

2016-08-03

Termination date

2017-05-08

Voluntary/Mandated

Voluntary: Firm initiated

Location

Horsham, PA, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-1451-2016