CHNaO Fluorescein Sodium Ophthalmic Strips recalled over sterility concerns

Recall date

December 31, 2025

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Official notice title

Wizcure Pharmaa Private Limited recalls CHNaO Fluorescein Sodium Ophthalmic Strips, USP 1mg, packaged as a) 100-count box, NDC 83851-100-10; b) 300-count box,…

Recall number

D-0350-2026

FDA classification

Class II

Brand / firm

Wizcure Pharmaa Private Limited

Sold / distributed

Distributed Nationwide in the USA

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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,