NDC 63323-193
Irinotecan Hydrochloride 20 mg per 1 mL injection, solution
On the label: Fresenius Kabi, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Melrose Park, IL, United States | Makes it and tests it | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Recalls
- Jan 22, 2013 · Class II · Fresenius Kabi USA LLC (FK USA)
Crystallization: Active pharmaceutical ingredient is precipitating in product solution.
Lots: Lot #: 872CZ00101, Exp 12/13
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, solution, intravenous
- Strength
- 20 mg per 1 mL
- Approval
- ANDA ANDA077776
- On the market since
- Apr 1, 2009
- Package NDCs
63323-193-5263323-193-55- Official label
- DailyMed (National Library of Medicine), updated Jan 19, 2023
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