FDA recall D-0351-2026

Wizcure Pharmaa Private Limited · Class II · drug

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.

Reason for recall

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Distribution

Distributed Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2025-12-31
Report date
2026-03-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bhiwadi, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0351-2026