Teva mitoXANTRONE Injection Recall: Impurity Risk in Concentrate
Teva recalls mitoXANTRONE Injection USP (concentrate) due to potential impurity issues that could affect safety. Affected lots expire by 2018; check NDC 0703-4685-01 for details.
Recall notice
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
Contact the company
What happened, in plain English
Teva is recalling mitoXANTRONE Injection USP (concentrate) because it may not meet impurity standards over time. This could pose a risk to patients using the medication, though the exact danger isn't specified in the recall. Read more at govinfonow.com/recall/42444-teva-mitoxantrone-injection-recall-impurity-risk-in-concentrate.
Source Summary by GovInfoNow · govinfonow.com/recall/42444-teva-mitoxantrone-injection-recall-impurity-risk-in-concentrate · Updated October 9, 2026 · FDA enforcement record: FDA #D-0095-2017
Cite this page
“Teva mitoXANTRONE Injection Recall: Impurity Risk in Concentrate.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42444-teva-mitoxantrone-injection-recall-impurity-risk-in-concentrate. Based on FDA recall #D-0095-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0095-2017%22&limit=1).
Why it’s dangerous
The medication may contain impurities that could change over time, potentially affecting safety. However, the recall does not specify how this impurity could cause harm or what the exact risk level is.
Who’s affected
Patients prescribed mitoXANTRONE Injection USP (concentrate) by a doctor are affected. Those using the recalled lots (NDC 0703-4685-01) are most at risk.
How to tell if you have this one
Check for the NDC code 0703-4685-01 on the vial label. The affected lots have specific expiration dates: September 2016, July 2017, November 2017, December 2017, or February 2018.
- Brand
Teva- Category
Drug
What to do — step by step
Check Vial Label
Look for the NDC code 0703-4685-01 and the lot numbers listed in the recall.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 8 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
How can I tell if my vial is recalled?
Check for the NDC code 0703-4685-01 and lot numbers: 31318574B (exp 09/16), 31319610B (exp 07/17), 31320058B (exp 11/17), 31320497B (exp 12/17), or 31320744B (exp 02/18).
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0095-2017 (September 13, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0095-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.