Teva Pharmaceuticals USA recalls mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medi
Recalled October 19, 2016 · FDA recall D-0095-2017 · Teva Pharmaceuticals USA
Hazard
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life. · FDA Class III
Units
11,214 vials
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
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.
Manufacturer(s)
Teva Pharmaceuticals USA
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →