NDC 0143-9583
Irinotecan Hydrochloride 20 mg per 1 mL injection
On the label: Hikma Pharmaceuticals USA Inc..
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Thymoorgan GMBH Pharmazie | Goslar OT Vienenburg, Germany | Makes it, tests it, packages it and labels it | Problems found, fixed voluntarilyMar 26, 2025 · 9 inspections |
Recalls
- Jun 11, 2020 · Class II · Hikma Pharmaceuticals USA Inc.
Defective Container: Customer complaints received of a crimp defect while removing the flip-cap during use.
Lots: Lot #:AC0231A, exp. date 08/2021
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Irinotecan: every company that makes it
- Form
- injection, intravenous
- Strength
- 20 mg per 1 mL
- Approval
- ANDA ANDA091032
- On the market since
- Dec 20, 2010
- Package NDCs
0143-9583-01- Official label
- DailyMed (National Library of Medicine), updated Jun 28, 2020
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