Drug 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,
D-0350-2026
Product summary
- Event
- Event 98253
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 10,080 boxes
- Official record key
drug-enforcement:D-0350-2026
Official wording
Reason: Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Code information: All lots
Distribution pattern: Distributed Nationwide in the USA
Derived failure modes
-
Sterility assurance
Lack of Assurance of Sterility