D-0352-2026 Class II Ongoing
Recall Details
- Product Type
- Drugs
- Report Date
- March 4, 2026
- Initiation Date
- December 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 184,320 containers
Product Description
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.
Reason for Recall
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
All lots