Vista Hypromelose Dry Eye Relief Eye Drops Recalled Due to Sterility Concerns
Vizcure Pharmaa Private Limited is recalling Vista Hypromelose Dry Eye Relief eye drops due to lack of assurance of sterility. The products were not manufactured in conformance with current good manufacturing practices.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
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 with sterility concerns for eye drops. No illnesses or injuries have been reported, but the hazard is theoretical and involves a risk-of-harm product due to potential contamination from lack of sterility assurance.
Plain-English summary
Vizcure Pharmaa Private Limited is recalling all lots of Vista Hypromelose Dry Eye Relief (Hypromelose) eye drops, 10 ml gel bottles, distributed nationwide in the USA. The recall affects 17,280 cartons of this over-the-counter eye drop product manufactured in India and distributed by hi-health in Scottsdale, Arizona.
The recall is being initiated because the products have not been manufactured in conformance with current good manufacturing practices, resulting in a lack of assurance of sterility. This means the eye drops may not meet the required sterile standards for ophthalmic use.
Consumers who have this product should stop using it immediately. They can return the product to the place of purchase for a full refund or contact hi-health for instructions on returning the product. No illnesses or injuries have been reported in connection with this recall.
The recalled product
- Product
- VISTA HYPROMELLOSE DRY EYE RELIEF (HYPROMELLOSE)
- Brand
- VISTA HYPROMELLOSE DRY EYE RELIEF
- Manufacturer
- Wizcure Pharmaa Private Limited
- Category
- Drug — OTC Eye Drops
- Hazard
- Affected units
- 17,280
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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