90%Confidence
0Views
FDASource
2026-04-17Date
Summary
Additional sterility failures for K.C. Pharmaceuticals' lubricating eye drops distributed through Cardinal Health and Harris Teeter indicate systemic manufacturing quality issues. This expands the scope of potentially contaminated products in the market.
Actionable: Expand recall efforts to include all K.C. Pharmaceuticals eye drop products and notify all distribution partners.
AI Confidence: 90%
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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