Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Hospira Australia Pty Ltd | Mulgrave, Australia | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilySep 2, 2022 · 6 inspections, 1 with FDA action |
Recalls
- Mar 15, 2021 · Class II · Cardinal Health Inc.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Lots: H074437AA
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Methotrexate: every company that makes it
- Form
- injection, solution, intramuscular; intravenous; subcutaneous
- Strength
- 25 mg per 1 mL
- Approval
- NDA NDA011719
- On the market since
- Sep 25, 2014
- Package NDCs
61703-350-0961703-350-10- Official label
- DailyMed (National Library of Medicine), updated Oct 29, 2026
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