90%Confidence
0Views
FDASource
2026-03-15Date
Summary
FDA issues Class II recall for BioGlo Fluorescein Sodium Ophthalmic Strips due to sterility concerns from non-compliance with cGMP at Omni Lens. This signals potential supply chain and quality control risks for HUB Pharmaceuticals and may impact patient safety in ophthalmic diagnostics.
Actionable: Monitor HUB Pharmaceuticals for potential financial or reputational impact and consider alternative suppliers for ophthalmic diagnostic products.
AI Confidence: 90%
Data Points
firmWizcure Pharmaa Private Limited
classificationClass II
statusOngoing
distributionDistributed Nationwide in the USA
productBioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpur
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