NDC 0143-9701
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 #: AC0231, AC0235, exp. date 08/2021; AC0237, exp. date 09/2021 - Sep 23, 2013 · Class II · West-Ward Pharmaceutical Corp.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Lots: Lot #: AC0020, Exp 03/14; AC0023, AC0025, Exp 08/14 - Sep 23, 2013 · Class II · West-Ward Pharmaceutical Corp.
Superpotent Drug: a recent review of the USP revealed that an incorrect calculation was used to determine the amount of irinotecan to use in formulation which will result in an assay higher than the labeled claim.
Lots: Lot #: AC0026, AC0027, Exp 10/14
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
0143-9701-01- Official label
- DailyMed (National Library of Medicine), updated Jun 23, 2020
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