85%Confidence
0Views
FDASource
2026-03-14Date
Summary
A second Class II recall for Bio Glo Fluorescein Sodium Ophthalmic Strips reinforces systemic manufacturing issues at Omni Lens affecting HUB Pharmaceuticals. The repeated sterility failures indicate deeper quality management problems that could lead to regulatory scrutiny and loss of customer trust.
Actionable: Assess exposure to HUB Pharmaceuticals and Omni Lens in supply chains, and evaluate competitor products for market opportunities.
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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