Teva Pharmaceuticals USA recalls mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Med…

Recall date

September 13, 2016

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0095-2017

FDA classification

Class III

Brand / firm

Teva Pharmaceuticals USA

Sold / distributed

Nationwide

Why it was recalled

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

Class III means the product violates regulations but is not likely to cause harm.

What was recalled

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.