FDA-Drug2026-03-04Class IIPROCESSING DEFECT
BioGlo Fluorescein Sodium Ophthalmic Strips recalled for sterility concerns
What this means
BioGlo Fluorescein Sodium Ophthalmic Strips were not manufactured according to safety standards, raising concerns about sterility. The strips are used by eye care professionals for diagnostic eye exams. All lots distributed nationwide are affected.
- Stop using BioGlo Fluorescein Sodium Ophthalmic Strips (NDC 17238-900-11) immediately.
- Contact your eye doctor or clinic if you have used these strips recently.
- Do not dispose of the strips in household trash; ask your healthcare provider or pharmacist how to return or properly dispose of them.
The agency's original wording
Hazard
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Intended for
Adults
Illnesses reported
None reported
Sold states
Distributed Nationwide in the USA
Affected count
184,320 containers
Manufactured in
H - 881, N/A, Bhiwadi, N/A, India
Products
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.
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0352-2026Want us to check the next one for you?
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