FDA Drugs recall ·
Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips… recall
- Recall number
- D-0351-2026
- Date
- (initiated December 31, 2025)
- Company / brand
- Wizcure Pharmaa Private Limited
H - 881, Bhiwadi, N/A, India - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 50,400 Boxes
- Hazard tags
- Sterility Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
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.
Why was it recalled?
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
All lots
Distribution
Distributed Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0351-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.