Serious health hazard — there is a reasonable probability that use of or exposure to this product will cause serious adverse health consequences or death.
MitoXANTRONE Injection Recalled by Hospira Inc. Due to Failed Stability Specifications: Product is subpotent and has...
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 Hospira Inc. directly.
Affected Products
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).
Quantity: 13,792 Vials (U.S.)
Why Was This Recalled?
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Hospira Inc.
Hospira Inc. has 245 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report