Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens P...

FDA Recall #D-0351-2026 — Class II — December 31, 2025

Recall #D-0351-2026 Date: December 31, 2025 Classification: Class II Status: Ongoing

Product Description

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:[email protected], 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.

Recalling Firm

Wizcure Pharmaa Private Limited — Bhiwadi, N/A

Classification

Class II — May cause temporary or medically reversible adverse health consequences.

Product Type

Drugs

Product Quantity

50,400 Boxes

Distribution

Distributed Nationwide in the USA

Code Information

All lots

Status

Ongoing

Voluntary / Mandated

Voluntary: Firm initiated