CLASS III Drug recall · Reported 3 Aug 2016 · FDA Enforcement Report
mitoXANTRONE Injection USP (concentrate), 20 mg recalled
Teva North America is recalling mitoXANTRONE Injection USP (concentrate), 20 mg/ (2 mg/mL) Multiple Dose, distributed nationwide in the US. The recall was initiated on 31 May 2016 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1451-2016
- FDA event ID
- 74514
- Recalling firm
- Teva North America, Horsham, PA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 31 May 2016
- FDA classified
- 28 Jul 2016
- Reported
- 3 Aug 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Injectable & IV Drugs
Timeline
| 31 May 2016 | Recall initiated by company | |
| 28 Jul 2016 | Classified by FDA | +58 days |
| 3 Aug 2016 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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.
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Which lots are affected?
Lot # 31318659B, Exp 02/17
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Teva North America
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Claravis (isotretinoin capsules USP), 10mg recalled | Teva North America | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Injection USP 40 mg/ (2 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Eptifibatide Injection 75 mg/ (0.75 mg/mL) single use vial recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Linezolid Injection 600 mg recalled by Teva North America | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Argatroban Injection in 0.9% Sodium Chloride 250 mg/ (1 mg/mL) recalled | Teva North America | Manufacturing (CGMP) Deviations | Nationwide |
Other Mitoxantrone (concentrate recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | mitoXANTRONE Injection USP (concentrate), 20 mg recalled | Teva Pharmaceuticals USA | Potency & Assay | Nationwide |