Over 75K eye care products recalled across US: See list of affected items
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.
Nearly 76,000 cases of AvKare eye drops have been recalled nationwide.
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.
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