Recalls / Class II
Class IID-0351-2026
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.
- Affected lot / code info
- All lots
Why it was recalled
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recalling firm
- Firm
- Wizcure Pharmaa Private Limited
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- H - 881, N/A, Bhiwadi, N/A N/A, India
Distribution
- Quantity
- 50,400 Boxes
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2025-12-31
- FDA classified
- 2026-02-25
- Posted by FDA
- 2026-03-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0351-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.