Urgent FDA recall: Nearly 76k eye care products pulled over major safety concerns: Check list of affected items

Hindustan Times

14-05-2025

The pharmaceutical consulting business BRS Analytical Services announced a countrywide recall of about 76,000 eye drop cases, as per FDA enforcement complaint.
According to AvKare, a medical firm that first notified the recall, the urgent recall comes after an FDA audit discovered many cGMP discrepancies, which are alterations from the regular manufacturing method used during pharmaceutical production.
The FDA also recalled the drops, which were intended to soothe dry, itchy eyes, because of a 'lack of assurance of sterility.'
While the eye drops' present threat to health is unknown, potential hazards cannot be completely ruled out, according to AvKare.
Customers have been advised to immediately stop use of the impacted products.
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
With expiration dates spanning from April 2025 to March 2027, the recalled items were distributed between May 2023 and April 2025.
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Consumers who want a complete refund, including shipping expenses, should return recalled items to AvKare.
They will receive a return slip if they fill out a form that may be found on AvKare's website. They can fax it to 931-292-6229 or email it to [e-mail].
After that, an organization will email the consumer a "Return to Authorization Form" so they can return the recalled item to the specified address and receive a complete refund, including shipping charges.