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
Wizcure Pharmaa, 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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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.

The Hazard

The recall stems from a lack of assurance of sterility. The products were not manufactured in compliance with current good manufacturing practices, posing potential health risks to users.

Reported Incidents

As of now, no incidents or injuries have been reported related to this recall. The potential health risks associated with using non-sterile ophthalmic strips include infection.

What to Do

Consumers and healthcare providers should stop using the recalled products immediately. Contact Wizcure Pharmaa Private Limited or your healthcare provider for further guidance.

Contact Information

For more information, contact Wizcure Pharmaa at [phone number not provided]. You can also visit the FDA's website at the following link: https://www.accessdata.fda.gov/scripts/enforcement/enforce_rpt-Product-Tabs.cfm?recall_number=D-0350-2026.

Key Facts

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

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Safety Assessment

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

Product Classification

Product Details

Model Numbers
100-count, NDC 83851-100-10
300-count, NDC 83851-100-30
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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