Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Kabi USA, LLC | Grand Island, NY, United States | Makes it and tests it | Problems found, fixed voluntarilyOct 13, 2023 · 14 inspections, 2 with FDA action |
Recalls
- May 22, 2019 · Class III · Fresenius Kabi USA, LLC
Failed Impurities/Degradation Specifications.
Lots: Lot #: 6018699, Exp. 12/2021 - Sep 27, 2012 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility: Glass vials may have finish fractures and glass particles.
Lots: Lot 6003930, exp. date 04/2014
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Ondansetron: every company that makes it
- Form
- injection, intramuscular; intravenous
- Strength
- 2 mg per 1 mL
- Approval
- ANDA ANDA076974
- On the market since
- Nov 18, 2009
- Package NDCs
63323-374-20- Official label
- DailyMed (National Library of Medicine), updated Nov 2, 2023
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