Moderate riskFDA DrugClass II

Vista Gonio Eye Lubricant recalled for lack of assurance of sterility

Vista Gonio Eye Lubricant (hypromellose ophthalmic solution) distributed by hi-health was not manufactured following required safety standards, raising concerns about sterility. All lots of this eye drop product are affected. No injuries have been reported to date.

From the FDA notice · Read the official notice ↗

What to do

  1. Stop using Vista Gonio Eye Lubricant immediately
  2. Do not apply the product to your eyes
  3. Contact your eye doctor or pharmacist for an alternative dry eye relief product
  4. Dispose of the bottle safely

Is yours affected?

Compare your label or packaging with the recalled product.

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.
Sold in
Nationwide
Made for
All ages (0 months and older)

This recall covers 7 products — see all of them.

Details

Units affected
139,104 cartons
Illnesses reported
None reported
Manufactured in
H - 881, N/A, Bhiwadi, N/A, India
Classification
Class II
Recall number
D-0349-2026

In the FDA's words

Description
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. Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices. All lots Distribution: Distributed Nationwide in the USA Affected quantity: 139,104 cartons
Hazard
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.

7 products in this recall

Vista, Bio Glo and CHNaO eye products recalled for sterility

Wizcure Pharma is recalling seven eye products sold nationwide: Vista dry eye drops (Vista Tears, Vista Gel, Vista Meibo Tears and Vista Gonio), Bio Glo and BioGlo fluorescein diagnostic test strips, and CHNaO fluorescein test strips. The FDA says the products were not made under current good manufacturing practices, so the company cannot assure they are sterile. No injuries have been reported.

The agency lists each product separately. Check every one you might have.

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