FDA Recall Terminated Historical recordClass III
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
- Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
- Published
- August 3, 2016
- Distribution
- Nationwide
