85%Confidence
0Views
FDASource
2026-04-19Date
Summary
Sterility assurance failures for tetrahydrozoline eye drops distributed through Walgreens and Perrigo channels indicate systemic manufacturing problems at K.C. Pharmaceuticals. This affects both store brands and national brands, creating significant retail disruption.
Actionable: Coordinate with Walgreens and Perrigo to implement immediate product recalls and customer notifications.
AI Confidence: 85%
Data Points
firmK.C. Pharmaceuticals, Inc
classificationClass II
statusOngoing
distributionNationwide in the US
productSterile Eye Drops ORIGINAL FORMULA (tetrahydrozoline HCl 0.05%), 0.5 FL OZ (15mL) bottles; a) Good Sense Sterile Eye Drops, Distributed By: Perrigo Di
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