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Home › FDA recalls › CHNaO Fluorescein Sodium Ophthalmic Strips
CLASS II · ModerateFDA

Wizcure Pharmaa Private Limited recalls CHNaO Fluorescein Sodium Ophthalmic Strips

📅 Dec 31, 2025 · 📍 Nationwide
Recalling company
Wizcure Pharmaa Private Limited
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,
Reason
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Classification
Class II – may cause temporary or medically reversible health consequences
Recall date
Dec 31, 2025
Reported
Mar 4, 2026
Distribution
Distributed Nationwide in the USA
Status
Ongoing
Quantity
10,080 boxes
Lot / codes
All lots
Company location
Bhiwadi, N/A
Recall type
Voluntary: Firm initiated
Recall number
D-0350-2026
Agency
U.S. Food and Drug Administration (FDA)

View official FDA notice ↗ Search recall number D-0350-2026 in the FDA Enforcement Report. Also see FDA recall press releases.

If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.