Vista Gonio Eye Lubricant Recalled Due to Sterility Concerns
Vista Gonio Eye Lubricant eye drops are being recalled because they may not be sterile. The product was not manufactured according to proper sterile drug-making standards.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall for sterility failure in an eye product. Sterile eye drops with manufacturing quality issues pose significant risk of eye infection, but no reported injuries or illnesses exist in the source text.
Plain-English summary
Vista Gonio Eye Lubricant (hypromellose ophthalmic solution) is being recalled nationwide. The product may not be sterile because it was not manufactured in conformance with current good manufacturing practices for sterile drugs.
The recall affects 139,104 cartons distributed in the USA. All lots of the product are included in this recall.
Consumers should stop using the product immediately. They should return the product to the point of purchase for a refund or dispose of it safely. No illnesses have been reported in connection with this product.
The recalled product
- Product
- VISTA GONIO EYE LUBRICANT (HYPROMELLOSE OPHTHALMIC SOLUTION)
- Brand
- VISTA GONIO EYE LUBRICANT
- Manufacturer
- Wizcure Pharmaa Private Limited
- Category
- Drug — Ophthalmic Solution
- Affected units
- 139,104
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- All lots
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 7 recalled by Wizcure Pharmaa Private Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
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