Topoisomerase Inhibitor
Where is Mitoxantrone made?
3 companies sell it under their own name. Their labels name 3 factories in the United States, India and China.
United States 1India 1China 1
Companies and their factories
| Company on the label | Factory | Where | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi, LLC2 mg per 1 mL · NDC 63323-132 | Fresenius Kabi USA, LLCMakes it | Melrose Park, IL, United States | Problems found, fixed voluntarilyAug 2023 |
| Hospira, Inc.2 mg per 1 mL · NDC 61703-343 | Zydus Hospira Oncology Private LimitedMakes it, tests it, packages it and labels it | Ahmedabad, India | Problems found, fixed voluntarilyJun 2023 |
| Meitheal Pharmaceuticals Inc.2 mg per 1 mL · NDC 71288-178, 71288-179 | Kindos Pharmaceuticals Co., Ltd.Makes it | Chengdu, China | Problems found, fixed voluntarilyJul 2024 |
Recalls
- Dec 3, 2014 · Class I · Hospira Inc.
Failed Stability Specifications: Product is subpotent and has out of specification known and unknown impurities.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.