96%Confidence
1Views
FDASource
2026-03-11Date
Summary
A second sterility recall for a higher-count package of the same ophthalmic product suggests systemic manufacturing problems at Omni Lens. This amplifies compliance risks and could lead to broader regulatory scrutiny for HUB Pharmaceuticals' distributed products.
Actionable: Assess exposure to HUB Pharmaceuticals and Omni Lens-manufactured products, and review quality audits for related supply chains.
AI Confidence: 96%
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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