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🏥 FDA: K.C. Pharmaceuticals, Inc — Class II

healthcareactionableSource: FDA
95%Confidence
0Views
FDASource
2026-04-16Date

Summary

K.C. Pharmaceuticals' sterility issues extend to tetrahydrozoline eye drops affecting Walgreens and Perrigo brands, indicating widespread manufacturing quality system failures. This creates significant regulatory and legal exposure for all involved companies.

Actionable: Coordinate with all affected retailers to implement comprehensive recall and consumer notification programs.

AI Confidence: 95%

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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