Recalls / Class II
Class IID-0350-2026
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,
- Brand name
- C20h10na2o5 Fluorescein Sodium Ophthalmic Strips
- Generic name
- Fluorescein Sodium
- Active ingredient
- Fluorescein Sodium
- Route
- Ophthalmic
- NDC
- 83851-100
- Affected lot / code info
- All lots
Why it was recalled
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Recalling firm
- Firm
- Wizcure Pharmaa Private Limited
- Manufacturer
- Vistamerica USA
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- H - 881, N/A, Bhiwadi, N/A N/A, India
Distribution
- Quantity
- 10,080 boxes
- Distribution pattern
- Distributed Nationwide in the USA
Timeline
- Recall initiated
- 2025-12-31
- FDA classified
- 2026-02-25
- Posted by FDA
- 2026-03-04
- Status
- Ongoing
Source: openFDA Drug Enforcement endpoint. Recall record D-0350-2026. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.