FDA recall D-0352-2026

Wizcure Pharmaa Private Limited · Class II · drug

Product

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

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-0352-2026