Recalls / Class II

Class IID-0352-2026

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.

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

184,320 containers

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-0352-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.