CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-...
FDA Recall #D-0350-2026 — Class II — December 31, 2025
Product Description
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,
Reason for Recall
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recalling Firm
Wizcure Pharmaa Private Limited — Bhiwadi, N/A
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
10,080 boxes
Distribution
Distributed Nationwide in the USA
Code Information
All lots
Status
Ongoing
Voluntary / Mandated
Voluntary: Firm initiated