AvKare eye drops recalled over regulatory ‘deviations’ : NPR

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Richard Vogel/AP Pharmaceutical firm AvKare has issued a voluntary recall on a number of of its over-the-counter merchandise for dry and irritated eyes, citing regulatory "deviations" recognized throughout an audit by the Meals and Drug Administration.

"Well being Hazard to the consumer is unknown," AvKare stated in a press release on its web site. The "deviations could result in merchandise of unacceptable high quality, and it isn't potential to rule out affected person dangers ensuing from use of those merchandise."

These deviations may very well be something from points with packaging to issues that occurred throughout manufacturing. AvKare didn't specify what points had been recognized.

The 5 recalled merchandise embody lubricant eye drops and eye gels, which shoppers ought to instantly stop utilizing, AvKare warned. The objects affected have been shipped Could 26, 2023 via April 21, 2025.

The merchandise are:

NDC# 50268-043-15 Synthetic Tears Ophthalmic SolutionNDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1percentNDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic SolutionNDC# 50268-126-15 Lubricant Eye Drops SolutionNDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Answer Neither AvKare nor the FDA responded to NPR's requests for remark.

AvKare stated prospects are eligible for a full refund on their affected merchandise, together with the price of transport the returns.

Over-the-counter eye remedies have made headlines lately after a spate of contamination points affected dozens of manufacturers. Among the affected merchandise in previous recollects included eye drops from nationwide manufacturers like CVS Well being, Goal and Ceremony Help.