Recall Ledger

Bio Glo Fluorescein Sodium Ophthalmic Strips USP recall (Wizcure Pharmaa Private Limited)

DrugClass IIOngoing

Summary: Wizcure Pharmaa Private Limited is recalling 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, Scottsdal. Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

What is being recalled

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.

Why

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

How serious is it

Class II is the middle level: using or being exposed to this product may cause temporary or medically reversible health problems, and the chance of serious harm is remote.

Where it was sold

Distributed Nationwide in the USA

How to tell if yours is affected

All lots

What to do

Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.

Recall facts

Recall numberD-0351-2026
CategoryDrug
AgencyU.S. Food and Drug Administration (FDA)
SeverityClass II
StatusOngoing
Recall startedDecember 31, 2025
ReportedMarch 4, 2026
CompanyWizcure Pharmaa Private Limited
Company locationBhiwadi, N/A, India
Initiated byVoluntary: Firm initiated
Quantity50,400 Boxes

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