Over-the-counter ophthalmic products were voluntarily recalled due to a manufacturing deviation discovered during a U.S. Food and Drug Administration audit, a notice says.
Pharmaceutical distributor AvKARE was notified of the consumer level drug recall by the recalling firm, BRS Analytical Services LLC. The recall was issued for several products as a result of manufacturing deviations that “may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.”
The notice warns consumers to stop using the affected products immediately. AvKARE said the FDA is aware of the recall, and the health hazard linked to the items is unknown.
USA TODAY reached out to AvKARE for more information.
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When were the items distributed?
The recalled products were shipped from May 26, 2023, to April 21, 2025, AvKARE said.
Which products were voluntarily recalled?
AvKARE’s press release includes a detailed chart with the lot numbers and expiration dates of the recalled products below. A recall notice posted on the FDA’s website identified the amount of cases involved in the recall.
13,104 cases of Lubricant Eye Drops Solution; national drug code (NDC): 50268-126-15
32,876 cases of Carboxymethylcellulose Sodium Ophthalmic Solution; national drug code (NDC): 50268-068-15
14,333 cases of Polyvinyl Alcohol Ophthalmic Solution; national drug code (NDC): 50268-678-15
1,610 cases of Carboxymethylcellulose Sodium Ophthalmic Gel 1%; national drug code (NDC): 50268-066-15
13,872 cases of Artificial Tears Ophthalmic Solution; national drug code (NDC): 50268-043-15
What should consumers do?
Buyers who may have these recalled products in their inventory are urged to complete a downloadable PDF “Quality to Return” form attached to the recall notice and fax it to 931-292-6229 or email it to customerservice@avkare.com.
Then, the company will send the customer a “Return to Authorization Form” to ship the recalled product back to the listed address to get a full credit, including shipping costs.
Taylor Ardrey is a news reporter for USA TODAY. You can reach her at tardrey@gannett.com.
This article originally appeared on USA TODAY: Eye drops, artificial tears, more ophthalmic products recalled
