Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
mitoXANTRONE Injection USP (concentrate) Recalled by Teva North America Due to Failed Impurities/Degradation Specifications: High out of specification results...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Teva North America directly.
Affected Products
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.
Quantity: 2,506 vials
Why Was This Recalled?
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Teva North America
Teva North America has 12 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report