Over-the-counter ophthalmic products were voluntarily recalled due to a manufacturing deviation that was noted during a recent US Food and Drug Administration (FDA) audit. AvKARE released an urgent voluntary drug recall notice on its website that BRS Analytical Service, LLC is initiating a voluntary recall to the consumer level for several ophthalmic products.
The notice warns consumers to stop using the affected products immediately. the recall is being carried out with the knowledge of the FDA.
The following products are subject to the recall:
- NDC# 50268-043-15 Artificial Tears Ophthalmic Solution
- NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
- NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Solution
- NDC# 50268-126-15 Lubricant Eye Drops Solution
- NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Solution
These items were shipped from May 26, 2023, through April 21, 2025. Additional information about the affected products and lots can be found here.