FDA-Drug2026-03-04Class IIPROCESSING DEFECT
Bio Glo Fluorescein Sodium Ophthalmic Strips recalled for sterility concerns
OTHERNationwide distribution
Stop using Bio Glo Fluorescein Sodium strips
Bio Glo Fluorescein Sodium Ophthalmic Strips USP were not manufactured following proper sterility standards. These diagnostic strips, distributed nationwide, may not be sterile and could pose a safety risk if used in the eye.
- Stop using Bio Glo Fluorescein Sodium Ophthalmic Strips immediately
- Contact your eye care provider or pharmacist for a replacement
- Do not use these strips for eye exams or diagnostic procedures
- Check NDC 17238-900-30 on your product to confirm it is affected
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-0351-2026Don't want to check this manually?
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