drugs Class I Updated 2015-04-15

Hospira Inc. recalls MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only.

Recalled Product

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).

Hazard / Issue

Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: LOTS DISTRIBUTED IN THE UNITED STATES: a) Lot: Z054636AA, Expiry: December 2014; Lot: A014636AA, Expiry: April 2015; Lot: A024636AB, Expiry: July 2015. b) Lot: A014645AA, Expiry: November 2015. c) Lot: A014643AA, Expiry April 2015.
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