NDC 0338-0048
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 | Cleveland, MS, United States | Makes it, tests it, packages it, labels it and sterilizes it | Serious problems, FDA actionSep 29, 2025 · 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
- Feb 5, 2016 · Class II · Baxter Healthcare Corp.
PRESENCE OF PARTICULATE MATTER: Product complaint for the presence of particulate matter identified as an insect.
Lots: Lot # G120162, Exp 11/18 - Apr 21, 2014 · Class II · Baxter Healthcare Corp.
Presence of Particulate Matter: Nylon fibers found in a bottle of 0.9% sodium chloride for irrigation.
Lots: Lot # Gl09272; Exp 09/16
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 NDA017427
- On the market since
- Dec 31, 1974
- Package NDCs
0338-0048-020338-0048-030338-0048-040338-0048-05- Official label
- DailyMed (National Library of Medicine), updated Feb 21, 2014
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