NDC 65219-328
Sodium Chloride 9 mg per 1 mL injection, solution
On the label: Fresenius Kabi USA, LLC.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Fresenius Medical Care North America | Ogden, UT, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionMar 6, 2026 · 8 inspections, 1 with FDA action |
Recalls
- Mar 11, 2026 · Class II · Fresenius Kabi USA, LLC
Lack of Assurance of Sterility
Lots: Batch# 23DU10004, Exp Date: 04/30/2026; Batch# 23HU10006, Exp Date: 06/30/2026.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Sodium Cation: every company that makes it
- Form
- injection, solution, intravenous
- Strength
- 9 mg per 1 mL
- Approval
- ANDA ANDA207310
- On the market since
- Sep 19, 2017
- Package NDCs
65219-328-1065219-328-50- Official label
- DailyMed (National Library of Medicine), updated Aug 20, 2026
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