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,
Recalled August 3, 2016 · FDA recall D-1451-2016 · Teva North America
Hazard
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D. · FDA Class III
Units
2,506 vials
Sold at
Nationwide
Description
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
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.
Manufacturer(s)
Teva North America
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →