Class I
Terminated
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).
- Company
- Hospira Inc.
- Recall Initiated
- December 3, 2014
- Posted
- April 15, 2015
- Recall Number
- D-0433-2015
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 13,792 Vials (U.S.)
- Firm Location
- Lake Forest, IL, United States
Reason for Recall
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Distribution
US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.
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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