FDA-Drug2026-03-04Class II
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Wizcure Pharmaa Private Limited
Hazard
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Sold states
Distributed Nationwide in the USA
Affected count
50,400 Boxes
Manufactured in
H - 881, N/A, Bhiwadi, N/A, India
Products
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0351-2026Original summary
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, Opp. Sakar - III, Navrangpura, Ahmedabad - 380014, India, Email:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30. Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. All lots Distribution: Distributed Nationwide in the USA Affected quantity: 50,400 Boxes
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