Drug product
Vista Gel Hypromellose USP 0.3% w/v, Eye Drops Dry Eye Relief Lubricating Gel, 10 ml. (1/3 fl. oz), Wizcure Pharmaa PVT. LTD, H-881, Phase-3, RIICO Industrial Area, Bhiwadi-301019, India, Manufactured for and distributed by: hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260, NDC 77790-002-10.
D-0347-2026
Product summary
- Event
- Event 98253
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 17,280 cartons
- Official record key
drug-enforcement:D-0347-2026
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