Class III · Low risk Terminated
mitoXANTRONE Injection USP
Reason Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
mitoXANTRONE Injection USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
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.
- Recalling firm
- Teva Pharmaceuticals USA
- NDC code
- 0703-4685-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0095-2017
What should you do? A recall doesn't always mean your specific bottle is affected - it often applies to certain lots only. Check the lot number on your package against the FDA notice, and talk to your pharmacist before stopping any medication.
Other Mitoxantrone recalls
See all
Class I · High risk Terminated
MitoXANTRONE Injection
Reason Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
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