Teva North America recalls mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only…

Recall date

May 31, 2016

Source

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

Recall number

D-1451-2016

FDA classification

Class III

Brand / firm

Teva North America

Sold / distributed

Nationwide

Why it was recalled

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

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 packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.