FDA Drug recall D-0433-2015
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only
- FDA Drug
- Class I
- terminated
- Published 2015-04-15
On 2015-04-15 the FDA classified a Class I recall of MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only by Hospira, citing failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0433-2015 |
| Classification | Class I |
| Status | terminated |
| Initiated | 2014-12-03 |
| Published | 2015-04-15 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Hospira |
| Distribution | US |
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
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Identifiers
| ndc | 61703-343-18 |
|---|---|
| ndc | 61703-343-65 |
| ndc | 61703-343-66 |
| code_info | LOTS DISTRIBUTED IN THE UNITED STATES: a) Lot: Z054636AA, Expiry: December 2014; Lot: A014636AA, Expiry: April 2015;…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. |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0433-2015%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.