mitoXANTRONE Injection USP — Class III drug recall D-1451-2016
Terminated recall by Teva North America, reported 2016-08-03, distributed nationwide. Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
| Recall number | D-1451-2016 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva North America, Horsham, PA, United States |
| Recall initiated | 2016-05-31 |
| Classified | 2016-07-28 |
| Reported by FDA | 2016-08-03 |
| Terminated | 2017-05-08 |
| Distributed | Nationwide (US) |
| Quantity | 2,506 vials |
| Reason classes | specification failure |
| NDC | 00703-4685-01 |
| Lot numbers | 02/17, 31318659B |
Product
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
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-1451-2016. 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.