FDAHealthDecember 31, 2025
Wizcure Pharmaa Private Limited — 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 Phar
⚠️ Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Is this relevant to me?
- Geography
- Nationwide
- Source agency
- FDA
- Category
- Health
- Published
- December 31, 2025
Distributed Nationwide in the USA
What's affected?
- 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,
- Lot code
- s
Additional details
All lots
What should I do?
Recommended action
Class II recall. Voluntary: Firm initiated Quantity affected: 10,080 boxes.
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