FDAFDA · Food and drugs·Recall number D-1451-2016
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.
Published August 3, 2016 · Recall initiated: May 31, 2016
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Manufacturer
- Teva North America
- Distributor
- Nationwide
- Lot
- Lot # 31318659B, Exp 02/17
- Risk classification
- Class III
- Area (FDA)
- drug
- Country
- United States
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