D-0433-2015 Class I Terminated
FDA drug recall D-0433-2015 was initiated by Hospira Inc. on Dec 3, 2014 and is designated Class I. Reason for recall: Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities. The recall status is terminated (terminated Dec 2, 2016). Affected quantity: 13,792 Vials (U.S.).
Recall Details
- Product Type
- Drugs
- Report Date
- Apr 15, 2015
- Initiation Date
- Dec 3, 2014
- Termination Date
- Dec 2, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 13,792 Vials (U.S.)
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.
Distribution Pattern
US: Nationwide including Puerto Rico; Australia, Canada, Cyprus, Egypt, Ireland, Saudi Arabia, Qatar, Oman, Bahrain, and United Kingdom.
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.
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-0433-2015
- openFDA file date
- Oct 27, 2026
- Loaded by RegDataLab
- Oct 29, 2026