95%Confidence
0Views
FDASource
2026-04-16Date
Summary
K.C. Pharmaceuticals' sterility assurance failure for multiple eye drop products distributed through major retailers creates significant consumer safety concerns. This affects multiple store brands including Cardinal Health's LEADER and Perrigo's Good Sense products.
Actionable: Immediately review all products manufactured by K.C. Pharmaceuticals across retail partners for potential sterility issues.
AI Confidence: 95%
Data Points
firmK.C. Pharmaceuticals, Inc
classificationClass II
statusOngoing
distributionNationwide in the US
productArtificial Tears Sterile Lubricant Eye Drops (polyvinyl alcohol 0.5%, povidone 0.6%), 0.5 FL OZ (15 mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HE
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