85%Confidence
0Views
FDASource
2026-03-10Date
Summary
A second Class II recall for Bio Glo Fluorescein Strips reinforces systemic manufacturing problems at Omni Lens. Repeated sterility failures increase regulatory scrutiny and may lead to broader import alerts or contract losses for the manufacturer.
Actionable: Assess exposure to Omni Lens and its partners, as recurring recalls heighten financial and operational risks.
AI Confidence: 85%
Data Points
firmWizcure Pharmaa Private Limited
classificationClass II
statusOngoing
distributionDistributed Nationwide in the USA
productBio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura,
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