95%Confidence
0Views
FDASource
2026-04-18Date
Summary
Additional sterility failures for K.C. Pharmaceuticals' lubricating eye drops indicate systemic manufacturing quality issues. The involvement of multiple distributors suggests widespread market penetration of potentially contaminated products.
Actionable: Expand product recall to include all K.C. Pharmaceuticals eye drops and verify alternative suppliers for replacement stock.
AI Confidence: 95%
Data Points
firmK.C. Pharmaceuticals, Inc
classificationClass II
statusOngoing
distributionNationwide in the US
productUltra Lubricating Eye Drops (polyethylene 400 0.4%, propylene glycol 0.3%), Sterile, 0.5 FL OZ (15mL) bottles; a) LEADER, DISTRIBUTED BY CARDINAL HEAL
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