Class II · Moderate risk
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
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.
Affected NDC
17238-0900-11
Compare with the code on your package — it is the most precise check available.
Drug: Fluorescein Category: Eye Drops & Ophthalmic
- Recalling firm
- Wizcure Pharmaa Private Limited
- NDC code
- 17238-900-11
- Origin
- N/A, India
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0352-2026 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other Fluorescein recalls
See all
Class II · Moderate risk
CHNaO Fluorescein Sodium Ophthalmic Strips
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class III · Low risk
Fluorescein 2% Ophth
Subpotent Drug
Class II · Moderate risk
Ful-Glo
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Class II · Moderate risk
Ful-Glo
Failed Impurities/Degradation Specifications: The Active Pharmaceutical Ingredient (API) used in the product is not being manufactured to the current USP monograph in regard to Unspecified Impurities.
Other recalls by Wizcure Pharmaa Private Limited
All 2025 recalls
Class II · Moderate risk
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
CHNaO Fluorescein Sodium Ophthalmic Strips
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Gonio Eye Lubricant
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Meibo Tears Propylene Glycol 0.6% w/v Eye Drops Advanced…
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
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