D-0350-2026 Class II Ongoing
FDA drug recall D-0350-2026 was initiated by Wizcure Pharmaa Private Limited on December 31, 2025 and is designated Class II. Reason for recall: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. The recall status is ongoing. Affected quantity: 10,080 boxes.
Recall Details
- Product Type
- Drugs
- Report Date
- March 4, 2026
- Initiation Date
- December 31, 2025
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 10,080 boxes
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,
Reason for Recall
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Distribution Pattern
Distributed Nationwide in the USA
Code Information
All lots