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D-0351-2026Class II

Wizcure Pharmaa Private Limited

What this record is not

A recall record is reproduced as FDA published it, and the classification is FDA’s. SPEQ adds no interpretation, and a recall concerns the products and dates in the record — it is not a statement about a company’s other products or its current status.

Recalling firm
Wizcure Pharmaa Private Limited
Product type
Drug
Status
Ongoing
Report date
2026-03-04
Distribution
Distributed Nationwide in the USA
Firm state
N/A
Product quantity
50,400 Boxes
Initiated by
Voluntary: Firm initiated
SPEQ quality domain
Environmental Monitoring
Reason for recall

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

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:info@omnilens.in, Manufactured for & distributed by: HUB Pharmaceuticals, LLC, 8767 E Via de Ventura #175, Scottsdale, AZ, 85258, NDC 17238-900-30.

Code / lot info

All lots

Data: U.S. FDA. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification. Open the enforcement explorer →