Could cause temporary or reversible harm; serious harm is unlikely.
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
| Distributed by / for | hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260 |
| NDC | 77790-001-10 |
| Full product label | Vista Tears Polyethylene Glycol 400 0.4% w/v, Propylene Glycol 0.3% w/v Eye Drops, Dry Eye Relief, Lubricant Drops, Sterile 10 ml (1/3 fl. oz.), Manufactured by: RA/Drugs/ MFG/2019/196283, Omni Lens Pvt. Ltd. 5, Samrudhhi, Opposite:Sakar-III, Navrangpura, Ahmedabad-380014, INDIA. Manufactured for and distributed by hi-health, 15207 N. 75th Street, Suite #104, Scottsdale, AZ, 85260. NDC 77790-001-10. |
| Recalling firm | Wizcure Pharmaa Private Limited |
| Distribution | Distributed Nationwide in the USA |
| Quantity | 5,760 cartons |
| Recall initiated | 2025-12-31 |
| Report date | 2026-03-04 |
| Recall completed | — |
| Recall number | D-0346-2026 |
| Classification | Class II |
| FDA status | Ongoing |
| Origin on file | Bhiwadi N/A India |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗