Vista Gonio Eye Lubricant Recall Issued Due to Sterility Concerns
Wizcure Pharmaa Private Limited is recalling 139,104 cartons of Vista Gonio Eye Lubricant because the product lacks assurance of sterility and failed to meet manufacturing standards.
What Happened
Wizcure Pharmaa Private Limited has initiated a voluntary recall of Vista Gonio Eye Lubricant. The recall was prompted by a lack of assurance of sterility, as the products were not manufactured in conformance with current good manufacturing practices (CGMP).
Which Products Are Affected
The recall affects the following product distributed nationwide in the USA:
- Product Name: Vista Gonio Eye Lubricant, Hypromellose Ophthalmic Solution USP (Sterile Drops, Dry Eye Relief)
- Size: 15 ml (1/2 fl. oz.)
- NDC Number: 77790-022-15
- Recall Number: D-0349-2026
- Quantity: 139,104 cartons
- Code Information: All lots are included in this recall.
- Manufacturer: Wizcure Pharmaa Pvt. Ltd., Bhiwadi, India
- Distributor: hi-health, Scottsdale, AZ
What You Should Do
Consumers should immediately stop using the affected eye lubricant. The recall was initiated via letter notification. For further information regarding returns or refunds, consumers should contact the distributor, hi-health, or the point of purchase.
Why This Matters
Sterility is a critical requirement for ophthalmic products. A lack of sterility assurance means the product may be contaminated, which poses a serious risk of eye infections or other vision-related injuries to consumers.
Source
This information is based on an official report from the FDA.
Source: FDA Official Notice