Drug product
Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops. Dry Eye Relief, 15 ml. (1/2 fl. oz.), Wizcure Pharmaa Pvt. Ltd., H-881, Phase-3, RIICO Industrial Area, Bhiwadi-901019, INDIA, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-022-15.
D-0349-2026
Product summary
- Event
- Event 98253
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 139,104 cartons
- Official record key
drug-enforcement:D-0349-2026
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