Drug recall D-0433-2015
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).
Reason for recall
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Lots and codes
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.
Recall details
- Recalling firm
- Hospira Inc., Lake Forest, IL
- Quantity
- 13,792 Vials (U.S.)
- Distribution
- US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.
- Type
- Voluntary: Firm initiated
- Recall initiated
- December 3, 2014
- Terminated
- December 2, 2016
Related products
- mitoXANTRONE – drug information
- NDC 61703-343 Mitoxantrone · Mitoxantrone Hydrochloride 2 mg/mL · Hospira, Inc.