Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufactured Omni Lens Pvt Ltd 5 - Samruddhi, O
Summary
The FDA issued a Class II for Bio Glo Fluorescein Sodium Ophthalmic Strips USP, 300 diagnostic strips, Manufac by Wizcure Pharmaa Private Limited. Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices..
Details
Source
Drug Recall
External ID
D-0351-2026
Action Date
2026-03-04
Status
Ongoing
Category
drug
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.
Lot/Code Info: All lots
Quantity Affected: 50,400 Boxes
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
Type: Voluntary: Firm initiated
Recall Initiated: 2025-12-31
Company
Bhiwadi, N/A
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 39 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Wizcure Pharmaa Private Limited has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Wizcure Pharmaa Private Limited) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Wizcure Pharmaa Private Limited have FDA actions?
Wizcure Pharmaa Private Limited has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0351-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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