NDC 63323-032
Sodium Acetate 4 meq per 100 mL injection, solution, concentrate
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 | Problems found, fixed voluntarilyAug 24, 2023 · 13 inspections, 2 with FDA action |
Recalls
- Mar 4, 2022 · Class I · Fresenius Kabi USA, LLC
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
Lots: Lot #: 6124193, 6124196, 6124226, Exp 05/2022; 6124532, Exp 06/2022; 6125333, Exp 12/2022; 6125678, Exp 01/2023; 6126846, Exp 08/2023
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Acetate Ion: every company that makes it
- Form
- injection, solution, concentrate, intravenous
- Strength
- 4 meq per 100 mL
- Approval
- ANDA ANDA206687
- On the market since
- Oct 30, 2017
- Package NDCs
63323-032-0063323-032-04- Official label
- DailyMed (National Library of Medicine), updated Oct 11, 2024
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