REGULATORY INTELLIGENCE·Warning Letter
Baxter Healthcare Faces FDA Scrutiny Over Sterile Water Recall Due to Plastic Particulates
Baxter Healthcare Corporation faces significant regulatory scrutiny following a nationwide Class II recall of 125,496 bottles of Sterile Water for Irrigation due to plastic particulate matter. This event underscores critical quality control deficiencies at their Deerfield, IL facility, impacting supply chain reliability for essential medical products. Procurement and regulatory teams must assess immediate supply risks and evaluate Baxter's remediation plans.
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