BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips, Manufactured by Omni Lens...
FDA Recall #D-0352-2026 — Class II — December 31, 2025
Product Description
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:[email protected], Manufactured for & disibruted by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-11.
Reason for Recall
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recalling Firm
Wizcure Pharmaa Private Limited — Bhiwadi, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
184,320 containers
Distribution
Distributed Nationwide in the USA
Code Information
All lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated