Nearly 76,000 cases of eye drops have been recalled nationwide by BRS Analytical Services, a pharmaceutical consulting firm, according to an FDA enforcement report.
The urgent recall follows an FDA audit that found several cGMP deviations, which are departures from the standard manufacturing process during pharmaceutical production, according to AvKare, a medical manufacturer that originally reported the recall.
The drops, used to relieve itchy, dry eyes, were also recalled due to a “lack of assurance of sterility,” according to the FDA.
The current health hazard posed to users of the eye drops is unknown, but possible risks cannot be ruled out, AvKare said. Customers should immediately stop use of the impacted products.
Eye products that have been recalled so far:
- 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
The recalled products were shipped out May 2023 through April 2025, and have expiration dates ranging from April 2025 through March 2027.
Customers can return the recalled products to AvKare for a full refund, including shipping costs.
They should complete a form linked on AvKare’s website and then fax or email it to the company to receive a return slip.
[Notigroup Newsroom in collaboration with other media outlets, with information from the following sources]
