FDA Drug recall D-0095-2017
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine…
- FDA Drug
- Class III
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class III recall of mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial, Rx only, Teva Parenteral Medicines, Inc., Irvine… by Teva Pharmaceuticals Usa, citing failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0095-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-09-13 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva Pharmaceuticals Usa |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Identifiers
| code_info | Lot Numbers: 31318574B, Exp 09/16; 31319610B, Exp 07/17; 31320058B, Exp 11/17; 31320497B, Exp 12/17; 31320744B, Exp 02/18 |
|---|
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-0095-2017%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.