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Baxter Healthcare Corporation: Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-

DrugsSource: FDA (drug) · Date: 2026-02-04

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The text below is copied from the official FDA (drug) record. If anything differs, the official notice is correct.

Company / brand
Baxter Healthcare Corporation
Product
Sterile Water for Irrigation, 250 mL, Single-Dose Plastic Bottle, Rx Only, Baxter Healthcare Corporation Deerfield, IL 60015 NDC: 0338-0004-02.
Reason / hazard
Presence of particulate matter: plastic particles from the bottle rim were observed floating into the solution
Classification
Class II
Status
Ongoing
Distribution / sold at
Nationwide
Recall initiated
2025-12-22
Code info
Lot #: G171359, expiry: 05/31/2027
Product quantity
125,496 bottles
Voluntary mandated
Voluntary: Firm initiated
City
Deerfield
State
IL
Country
United States
Event id
98178
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