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).
Reported: April 15, 2015 Initiated: December 3, 2014 #D-0433-2015
Product Description
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).
Reason for Recall
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Details
- Recalling Firm
- Hospira Inc.
- Units Affected
- 13,792 Vials (U.S.)
- Distribution
- US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.
- Location
- Lake Forest, IL
Frequently Asked Questions
What product was recalled? ▼
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).. Recalled by Hospira Inc.. Units affected: 13,792 Vials (U.S.).
Why was this product recalled? ▼
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on April 15, 2015. Severity: Critical. Recall number: D-0433-2015.
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