FDA Drug recall D-1451-2016
mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Me…
- FDA Drug
- Class III
- terminated
- Published 2016-08-03
On 2016-08-03 the FDA classified a Class III recall of mitoXANTRONE Injection USP (concentrate), 20 mg/10 mL (2 mg/mL), 10 mL Multiple Dose Vial packaged in a carton, Rx only, Teva Parenteral Me… by Teva North America, citing failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-1451-2016 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-05-31 |
| Published | 2016-08-03 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Teva North America |
| Distribution | US |
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
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Identifiers
| code_info | Lot # 31318659B, Exp 02/17 |
|---|
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-1451-2016%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.