NDC 0338-0004

Sterile Water 100 mL per 100 mL irrigant

On the label: Baxter Healthcare Corporation.

United States: 1

Where it's made

FactoryWhereRoleLast FDA inspection
Baxter Healthcare CorporationCleveland, MS, United StatesMakes it, tests it, packages it, labels it and sterilizes it Serious problems, FDA actionSep 29, 2025 · 9 inspections, 3 with FDA action
Baxter Healthcare CorporationRound Lake, IL, United StatesTests it Serious problems, FDA actionApr 2, 2026 · 15 inspections, 2 with FDA action

Recalls

Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.

Product details

Generic drug
Water: every company that makes it
Form
irrigant, irrigation
Strength
100 mL per 100 mL
Approval
NDA NDA017428
On the market since
Dec 31, 1974
Package NDCs
0338-0004-02 0338-0004-03 0338-0004-04 0338-0004-05
Official label
DailyMed (National Library of Medicine), updated Oct 17, 2017

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