A recall has been issued for certain over-the-counter eye drops, due to a risk that they may not be sterile, posing an eye infection risk for consumers.
The U.S. Food and Drug Administration (FDA) announced a Puriton Eye Relief Drops recall on November 7, warning customers they should immediately stop using the eye drops to avoid vision-threatening injuries. To date, the FDA is not aware of any injuries associated with the recalled eye drops.
The recalled eye drops were sold “over-the-counter”, and are designed to provide consumers with temporary relief of an eye infection and dry eyes. However, during a routine FDA inspection, investigators found the company was not manufacturing the eye drops with the necessary production control and conditions to assure sterility. The agency warns that this poses a variety of vision-threatening side effects to consumers.
Using non-sterile eye drops containing increased levels of pH could cause direct destruction of tissues in the cornea, anterior chamber and deeper structures of the eye that may lead to scarring, glaucoma, and total vision loss, the FDA warns.
The recall includes all lots of Purition Eye Relief Drops sold in 0.5 ounce (15ml) plastic bottles marked with UPC code 7 36972 1679 0. The recalled eye drops were manufactured by Kadesh, Inc. of Garden Grove, California. They were distributed across the nation to various retailers.
Kadesh indicates it will send letters to distributors and customers notifying them of the potential contamination hazards, as well as providong instructions on how to arrange a return. Customers with additional questions or concerns regarding the recall are encouraged to email the Kadesh Recall Department at email@example.com.
FDA officials urge customers who may have used the contaminated eye drops to consult with a primary healthcare professional immediately. Customers may also report any adverse reactions to the FDA’s MedWatch Adverse Event Reporting program.