FDAHealthDecember 31, 2025
Wizcure Pharmaa Private Limited — BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gu
⚠️ Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 31, 2025
Distributed Nationwide in the USA
What's affected?
- Product
- BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens PVT. Ltd., 5 - Samrudhhi, Opp. Sakar-III, Navrangpura, Ahmedabad, Gujarat, India - 380014, Email:info@omnilens.in, Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
- Lot code
- s
Additional details
All lots
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 184,320 containers.
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