MitoXANTRONE Injection — Class I drug recall D-0433-2015
Terminated recall by Hospira Inc., reported 2015-04-15, distributed nationwide. Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impuritie
| Recall number | D-0433-2015 |
|---|---|
| Product type | Drug |
| Classification | Class I |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Hospira Inc., Lake Forest, IL, United States |
| Recall initiated | 2014-12-03 |
| Classified | 2015-04-06 |
| Reported by FDA | 2015-04-15 |
| Terminated | 2016-12-02 |
| Distributed | Nationwide (US) |
| Countries outside the US | AU, BH, CA, CY, EG, GB, IE, OM, QA, SA |
| Quantity | 13,792 vials |
| Reason classes | potency, specification failure |
| NDC | 61703-0343, 61703-0343-18, 61703-0343-65, 61703-0343-66 |
| Lot numbers | A014636AA, A014643AA, A014645AA, A024636AB, Z054636AA |
| Expiration dates | 2014-12-20, 2015-04-20, 2015-07-20, 2015-11-20 |
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.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0433-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.