FDA recall D-0349-2026

Wizcure Pharmaa Private Limited · Class II · 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.

Reason for recall

Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

Distribution

Distributed Nationwide in the USA

Key facts

Status
Ongoing
Initiation date
2025-12-31
Report date
2026-03-04
Voluntary/Mandated
Voluntary: Firm initiated
Location
Bhiwadi, N/A, India

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0349-2026