mitoXANTRONE Injection USP — Class III drug recall D-0095-2017
Terminated recall by Teva Pharmaceuticals USA, reported 2016-10-19, distributed nationwide. Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throu
| Recall number | D-0095-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Teva Pharmaceuticals USA, North Wales, PA, United States |
| Recall initiated | 2016-09-13 |
| Classified | 2016-10-12 |
| Reported by FDA | 2016-10-19 |
| Terminated | 2017-05-05 |
| Distributed | Nationwide (US) |
| Quantity | 11,214 vials |
| Reason classes | specification failure |
| NDC | 00703-4685-01 |
| Lot numbers | 02/18, 07/17, 09/16, 11/17, 12/17, 31318574B, 31319610B, 31320058B, 31320497B, 31320744B |
Product
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine, CA 92618, NDC 0703-4685-01.
Reason for recall
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
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-0095-2017. 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.