HIGH

Wizcure Pharmaa Recalls Fluorescein Sodium Ophthalmic Strips Over Sterility Concerns

Wizcure Pharmaa recalled 10,080 boxes of Fluorescein Sodium Ophthalmic Strips on December 31, 2025, due to sterility issues. The recall affects products packaged in 100-count and 300-count boxes. Consumers should stop using these products immediately and consult healthcare providers for guidance.

Quick Facts at a Glance

Recall Date
December 31, 2025
Hazard Level
HIGH
Brands
C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS, Vistamerica USA
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

Fluorescein Sodium Ophthalmic Strips are used in medical settings for diagnostics in eye examinations. They help detect corneal abrasions and other eye conditions, making them essential for healthcare providers.

Why This Is Dangerous

The lack of sterility assurance means that these strips could introduce bacteria or other pathogens into the eye, leading to serious infections and complications.

Industry Context

This recall is not part of a broader industry pattern.

Real-World Impact

Consumers may face health risks from potential infections. Immediate cessation of product use is necessary, which may lead to inconvenience for healthcare providers and patients.

Practical Guidance

How to identify if yours is affected

  1. Check packaging for NDC numbers 83851-100-10 or 83851-100-30.
  2. Verify if the product was purchased within the specified timeline.
  3. Look for any signs of contamination or damage to the packaging.

Where to find product info

NDC numbers and other identifiers can typically be found on the product packaging or box.

What timeline to expect

Expect a refund or replacement processing time of 4-6 weeks after contacting the manufacturer.

If the manufacturer is unresponsive

  • Document all communications with the company.
  • Reach out to the FDA for further assistance.
  • Consider filing a complaint with consumer protection agencies.

How to prevent similar issues

  • Only purchase ophthalmic products from reputable manufacturers.
  • Check for FDA approval and sterility certifications before use.
  • Consult healthcare professionals for recommendations on safe products.

Documentation advice

Keep records of your purchase, including receipts and any correspondence with the manufacturer regarding the recall.

Product Details

The recalled products include Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged in 100-count boxes (NDC 83851-100-10) and 300-count boxes (NDC 83851-100-30). These products were manufactured by Wizcure Pharmaa PVT. LTD in India and distributed nationwide in the USA.

Key Facts

  • Recall date: December 31, 2025
  • Report date: March 4, 2026
  • Type: Fluorescein Sodium Ophthalmic Strips, 1mg
  • Quantity recalled: 10,080 boxes

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
UPC Codes
83851-100
83851-100-10
83851-100-30
+1 more
Affected States
ALL
Report Date
March 4, 2026
Source Agency
FDA - Drug Safety
Recall Status
ACTIVE

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