Why it was recalled
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Product description
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 numbers, UPCs & expiration codes
All lots
Where it was sold
Distributed Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0350-2026
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- Dec 31, 2025
- FDA report date
- Mar 4, 2026
- Quantity
- 10,080 boxes
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Wizcure Pharmaa Private Limited
Original FDA data
Every field from FDA enforcement report D-0350-2026, exactly as published.
Show all FDA fields
- City
- Bhiwadi
- Status
- Ongoing
- Country
- India
- Event ID
- 98253
- Address
- H - 881
- Code information
- All lots
- Report date
- Mar 4, 2026
- Product type
- Drugs
- Recall number
- D-0350-2026
- Classification
- Class II
- Recalling firm
- Wizcure Pharmaa Private Limited
- Product quantity
- 10,080 boxes
- Reason for recall
- Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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,
- Distribution pattern
- Distributed Nationwide in the USA
- Recall initiation date
- Dec 31, 2025
- Initial firm notification
- Letter
- Center classification date
- Feb 25, 2026