NDC 63323-972
Fosaprepitant 150 mg per 5 mL injection, powder, lyophilized, for 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
- Jul 13, 2020 · Class III · Fresenius Kabi USA, LLC
Labeling Error: Label Error on Declared Strength: Carton label and product insert incorrectly states the quantity of the excipient edetate disodium (EDTA) as 5.4 mg / vial, rather than the actual amount of 18.8 mg / vial.
Lots: Lot #: 6122760, 6122761, exp 08/2021; 6122762, exp 09/2021; 6123883, exp 03/2022
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Aprepitant: every company that makes it
- Form
- injection, powder, lyophilized, for solution, intravenous
- Strength
- 150 mg per 5 mL
- Approval
- ANDA ANDA206197
- On the market since
- Sep 5, 2019
- Package NDCs
63323-972-10- Official label
- DailyMed (National Library of Medicine), updated Jun 19, 2024
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