Drug product
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.
D-0346-2026
Product summary
- Event
- Event 98253
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 5,760 cartons
- Official record key
drug-enforcement:D-0346-2026
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