NDC 0338-0047
Sodium Chloride 900 mg per 100 mL irrigant
On the label: Baxter Healthcare Corporation.
Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Baxter Healthcare Corporation | Marion, NC, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionFeb 9, 2024 · 9 inspections, 3 with FDA action |
| Baxter Healthcare Corporation | Round Lake, IL, United States | Tests it | Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action |
Recalls
- Nov 19, 2019 · Class II · Baxter Healthcare Corporation
Lack of Assurance of Sterility: Product has the potential to leak.
Lots: Lot #: Y309971, Y309971A, Exp. date 6/30/2021
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
- irrigant, irrigation
- Strength
- 900 mg per 100 mL
- Approval
- NDA NDA017867
- On the market since
- May 30, 1980
- Package NDCs
0338-0047-240338-0047-270338-0047-29- Official label
- DailyMed (National Library of Medicine), updated Jul 17, 2018
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