NDC 0404-9904
Magnesium Sulfate 500 mg per 1 mL injection, solution
On the label: Henry Schein, Inc.. It's repackaged: Henry Schein, Inc. rebottles it from Fresenius Kabi, LLC's NDC 63323-064.
Where the pills inside were 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 |
| 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
- May 25, 2013 · Class I · Fresenius Kabi USA, LLC
Presence of Particulate Matter: Glass particulate matter was observed in a retention sample during an annual review.
Lots: Lot #: 6103882, 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
- Magnesium Cation: every company that makes it
- Form
- injection, solution, intramuscular; intravenous
- Strength
- 500 mg per 1 mL
- Approval
- NDA NDA019316
- On the market since
- Jan 18, 2022
- Package NDCs
0404-9904-02- Official label
- DailyMed (National Library of Medicine), updated Nov 2, 2026
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