Class III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: potential failure to meet the specification for Impurity D throughout shelf-life.
mitoXANTRONE Injection USP
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
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.
Affected NDC
0703-4685-01
Compare with the code on your package — it is the most precise check available.
Drug: Mitoxantrone
- Recalling firm
- Teva North America
- NDC code
- 0703-4685-01
- Origin
- PA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1451-2016 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Mitoxantrone recalls
See all
Class I · High risk
MitoXANTRONE Injection
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Other recalls by Teva North America
All 2016 recalls
Class III · Low risk
Claravis (isotretinoin capsules USP)
Failed Impurities/Degradation Specifications.
Class III · Low risk
Children's Qnasl 40 mcg
Failed Content Uniformity Specifications: out of specification test result for spray content uniformity.
Class II · Moderate risk
Amoxicillin for Oral Suspension USP
Superpotent drug: Out of specification test result for assay during stability testing.
Class II · Moderate risk
Albuterol Sulfate Syrup
Presence of Foreign Substance; presence of black particles describes generically as cellulose-based bundles of brown fibrous material.
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