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
Class I — High risk. Reasonable probability of serious harm or death.
Why it was recalled
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Cause type: Stability / shelf life
The product degraded or failed stability testing before its labeled expiry. Heat, moisture or time can break the drug down into degradants or reduce potency. All stability / shelf life recalls.
What was recalled
MitoXANTRONE Injection, USP, (concentrate) 2 mg/mL, Rx Only. Hospira, Lake Forest, IL 60045, Product of Australia. Available in a) 20 mg/10 mL Multi Dose Vial (NDC: 61703-343-18); b) 25 mg/12.5 mL Multi Dose Vial (NDC: 61703-343-65); c) 30 mg/15 mL Multi Dose Vial (NDC: 61703-343-66).
Affected NDCs
61703-0343-18
61703-0343-65
61703-0343-66
Compare with the code on your package — it is the most precise check available.
Drug: Mitoxantrone
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Mitoxantrone NDC 61703-0343 |
HYDROCHLORIDE 2 mg/mL | Injection, Solution, Concentrate Intravenous |
Hospira, Inc. | Rx |
- Recalling firm
- Hospira Inc.
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0433-2015 · FDA notice
Treat this as urgent. Class I means FDA judged there is a reasonable probability of serious harm. Find the lot number on your package; if it matches the recalled lots, do not take another dose before you have spoken to your pharmacist or prescriber - today, not next week. 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 III · Low risk
mitoXANTRONE Injection USP
Failed Impurities/Degradation Specifications: High out of specification results for Impurity D.
Other recalls by Hospira Inc.
All 2014 recalls
Class I · High risk
Infant 25% DEXTROSE Injection
Presence of Particulate Matter: human hair found within an internal sample syringe.
Class II · Moderate risk
Fentanyl Citrate Injection
Lack of Assurance of Sterility: Complaints of broken tips on the ampules.
Class II · Moderate risk
DOBUTamine Injection
Discoloration: Firm received complaints of product discoloration and particulates.
Class III · Low risk
5% Lidocaine HCL and 7.5% Dextrose Injection
Failed Stability Specifications: The recalled lots did not meet the specification for color and pH throughout shelf life.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.