C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS
Recalling Firm / Manufacturer: Wizcure Pharmaa Private Limited
(Bhiwadi, India)
FDA Recall Number: D-0350-2026
Source Authority Disclaimer: This drug recall notice is published by Questo using official enforcement reports issued by the U.S. Food & Drug Administration (FDA). It is provided for informational, academic, and clinical research purposes only. Patients should not discontinue prescribed treatments without consulting their physician or pharmacist.
Product & Identification Information
Brand, active ingredients, NDC codes, and manufacturer details
Brand / Trade Name
C20H10NA2O5 FLUORESCEIN SODIUM OPHTHALMIC STRIPS
Generic Name
FLUORESCEIN SODIUM
Active Substance(s)
Fluorescein Sodium
Administration Route
Ophthalmic
National Drug Code (NDC)
83851-100
Total Quantity Recalled
10,080 boxes
Official Reason for Recall
Specific hazard or quality defect cited by the FDA
According to the official FDA enforcement report:
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Full Product Description
Packaging specifications and labeling details
CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box, NDC 83851-100-30. Manufactured by Wizcure Pharmaa PVT. LTD, H-681, Phase 3, RIICO Industrial Area, Bhiwadi- 301019 INDIA, Vistamerica USA, 20 Perkins Dr. Prescott, AZ 86301, Vistamerica USA, Made in India,
Enforcement & Regulatory Details
FDA classification, report dates, and initiation authority
Health Hazard Classification
Class II
Current Action Status
Ongoing
FDA Enforcement Report Date
March 04, 2026
Firm Initiation Date
December 31, 2025
FDA Classification Date
Feb 25, 2026
Initiation Type
Voluntary: Firm initiated
Affected Lots & Batch Numbers
Product codes, lot numbers, and expiration dates
All lots
Distribution Information
Geographic scope of affected shipments
Distributed Nationwide in the USA
Safety Guidance & Actions
Standard FDA protocol for patients and healthcare providers
Patient Advisory
Check your prescription bottle or packaging against the affected lot numbers listed above. If your medication matches a recalled lot, contact your pharmacist for replacement guidance.
Healthcare Provider Guidance
Audit pharmacy stock and return affected lots to the distributor per manufacturer instructions. Notify patients where clinically indicated.
Official Source Provenance
Verified regulatory citation from U.S. FDA OpenFDA
Primary Data Source: U.S. Food & Drug Administration (FDA) OpenFDA API
Recall Number: D-0350-2026
Questo Retrieval Date: July 31, 2026 14:36 1785508606UTCC