Drug 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).
D-0433-2015
Product summary
- Firm
- Hospira Inc.
- Event
- Event 70064
- Status
- Terminated
- Classification
- Class I
- Quantity
- 13,792 Vials (U.S.)
- Official record key
drug-enforcement:D-0433-2015
Official wording
Reason: Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Code information: 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.
Distribution pattern: US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.
Derived failure modes
-
Potency or specification failure
subpotent