Class IIOngoing

CHNaO Fluorescein Sodium Ophthalmic Strips recall

FDA recall D-0350-2026 · initiated Dec 31, 2025

May cause temporary or medically reversible harm; low probability of serious harm.

Why it was recalled

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

Details

Product: 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,
Recalling company: Wizcure Pharmaa Private Limited
Classification: Class II
Status: Ongoing
Type: Voluntary: Firm initiated
Distribution: Distributed Nationwide in the USA
Initiated: Dec 31, 2025
FDA report date: Mar 4, 2026

What to do.If you have a recalled product, don't throw away questions — check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This page reproduces public FDA data and is not medical advice.

Source: openFDA Drug Enforcement record D-0350-2026 ↗

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