HIGH

BioGlo Ophthalmic Strips Recalled Over Sterility Concerns

BioGlo Fluorescein Sodium Ophthalmic Strips are recalled due to sterility issues. The recall affects 184,320 containers distributed nationwide in the USA. Consumers should stop using the product immediately.

Quick Facts at a Glance

Recall Date
December 31, 2025
Hazard Level
HIGH
Brand
Wizcure Pharmaa Private
Category
Health & Personal Care
Sold At
Multiple Retailers
Geographic Scope
1 states
At-Risk Groups
GENERAL

Hazard Information

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

What You Should Do

Consumers and healthcare providers should stop using this product immediately. Contact Wizcure Pharmaa Private Limited or your healthcare provider for guidance. Notification method: Letter

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About This Product

BioGlo Fluorescein Sodium Ophthalmic Strips are used for diagnostic purposes in eye examinations. They help in detecting corneal abrasions and other eye conditions, making them important for healthcare providers.

Why This Is Dangerous

The lack of assurance of sterility means that the product could be contaminated, posing a risk of infection to users. This is critical for products intended for use in the eye, where contamination can lead to serious complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face health risks if they have used the affected product. Immediate action is required to mitigate potential health issues.

Practical Guidance

How to identify if yours is affected

  1. Look for the product name 'BioGlo Fluorescein Sodium Ophthalmic Strips' on your packaging.
  2. Verify if the product is part of the recall by checking the lot number if available.
  3. If unsure, stop using the product and consult a healthcare provider.

Where to find product info

The product name and lot number are typically found on the box or container the strips come in.

What timeline to expect

Expect a realistic timeline of 4-6 weeks for refund processing after the product is returned.

If the manufacturer is unresponsive

  • Contact Wizcure Pharmaa directly via email or phone for assistance.
  • File a complaint with the FDA if there is no response.

How to prevent similar issues

  • Check for FDA recalls before purchasing medical products.
  • Look for products that have been certified for sterility by recognized organizations.
  • Consult with healthcare providers about the safety of medical products.

Documentation advice

Keep a copy of your purchase receipt, any emails or letters from the manufacturer, and document any symptoms or issues experienced.

Product Details

BioGlo Fluorescein Sodium Ophthalmic Strips USP, 100 diagnostic strips per container. Manufactured by Omni Lens PVT. Ltd. and distributed by HUB Pharmaceuticals, LLC. Recall date is December 31, 2025.

Key Facts

  • Recall initiated due to sterility concerns
  • 184,320 containers affected
  • Distributed nationwide in the USA
  • Manufactured by Omni Lens PVT. Ltd.
  • Contact Wizcure Pharmaa for more information

Safety Guide

Not sure what to do next? Our guide walks you through the process step by step.

Read: What to Do When You Find a Recalled Product

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Safety Assessment

Risk LevelHIGH
Severity Score
8/ 10
Affected Groups
GENERAL
Injury Types
OTHER

Product Classification

Product Details

Model Numbers
All lots
Affected States
ALL
Report Date
March 4, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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