NDC 61703-343
Mitoxantrone 2 mg per 1 mL injection, solution, concentrate
On the label: Hospira, Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Zydus Hospira Oncology Private Limited | Ahmedabad, India | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyJun 30, 2023 · 5 inspections |
Recalls
- Dec 3, 2014 · Class I · Hospira Inc.
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Lots: LOTS DISTRIBUTED IN THE UNITED STATES: a) Lot: Z054636AA, Expiry: December 2014; Lot: A014636AA, Expiry: April 2015; Lot: A024636AB, Expiry: July 2015. b) Lot: A014645AA, Expiry: November 2015. c) Lot: A014643AA, Expiry April 2015.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mitoxantrone: every company that makes it
- Form
- injection, solution, concentrate, intravenous
- Strength
- 2 mg per 1 mL
- Approval
- ANDA ANDA076871
- On the market since
- Apr 11, 2006
- Package NDCs
61703-343-1861703-343-6561703-343-66- Official label
- DailyMed (National Library of Medicine), updated Jul 14, 2025
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