AvKare eye drops recalled over regulatory ‘deviations’ : NPR

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 mentioned in an announcement on its web site. The “deviations might result in merchandise of unacceptable high quality, and it’s not potential to rule out affected person dangers ensuing from use of those merchandise.”

These deviations could possibly 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 embrace lubricant eye drops and eye gels, which customers ought to instantly stop utilizing, AvKare warned. The gadgets affected have been shipped Might 26, 2023 by way of April 21, 2025.

The merchandise are:

• NDC# 50268-043-15 Synthetic Tears Ophthalmic Resolution
• NDC# 50268-066-15 Carboxymethylcellulose Sodium Ophthalmic Gel 1%
• NDC# 50268-068-15 Carboxymethylcellulose Sodium Ophthalmic Resolution
• NDC# 50268-126-15 Lubricant Eye Drops Resolution
• NDC# 50268-678-15 Polyvinyl Alcohol Ophthalmic Resolution

Neither AvKare nor the FDA responded to NPR’s requests for remark.

AvKare mentioned clients are eligible for a full refund on their affected merchandise, together with the price of delivery the returns.

Over-the-counter eye therapies have made headlines in current years after a spate of contamination points affected dozens of manufacturers. A number of the affected merchandise in previous recollects included eye drops from nationwide manufacturers like CVS Well being, Goal and Ceremony Support.