Prestige Brand Holdings is recalling 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief distributed across the United States after regulators cited a lack of assurance of sterility and the possibility of contamination.
By yourNEWS Media Newsroom
Nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief are being recalled nationwide over concerns that the over-the-counter eye drops may not be sterile, according to an enforcement report published by the Food and Drug Administration this week.
Prestige Brand Holdings voluntarily recalled 39,060 bottles of the product after identifying a “lack of assurance of sterility,” with the FDA report stating that the action was initiated “due to potential contamination.”
The notice did not identify the type of possible contamination or explain how the sterility concern arose.
The affected product was distributed throughout the United States.
According to the FDA report, the recall applies specifically to Clear Eyes Maximum Itchy Eye Relief packaged in 15-milliliter bottles bearing lot code 2552A and an expiration date of Sept. 30, 2027.
The National Drug Code for the affected drops is 67172-999-01.
Prestige Brand Holdings initiated the recall July 29. The FDA formally classified it Aug. 14 before publishing the enforcement notice Aug. 19.
The agency designated the recall as Class II.
Under the FDA’s classification system, a Class II recall means that “use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”
The enforcement report did not provide specific instructions for consumers who possess the recalled Clear Eyes product. Recalled products can typically be returned to the retailer where they were purchased.
The recall is the latest in a series of actions involving eye drops and other ophthalmic products over contamination or sterility concerns.
In March, K.C. Pharmaceuticals recalled more than 3 million bottles of eye drops marketed under several different brand names because of sterility issues.
Another large recall followed in late July, when approximately 11 million packages of eye drops distributed nationwide were recalled because manufacturers could not provide adequate assurance that the products were sterile, according to an earlier FDA-related report.
Vietnam-based Rohto-Mentholatum Co., Ltd. recalled multiple lots of Rohto Cooling Eye Drops in different strengths as part of that action.
Eye-drop contamination has drawn increased regulatory attention following several major warnings and recalls in 2023.
That year, the FDA advised consumers to stop using more than two dozen over-the-counter eye-drop products because of concerns that contamination could cause eye infections and potentially lead to vision loss.
Those products were sold under several widely known retail and pharmaceutical brands, including CVS Health, Leader, Rite Aid, Target, Walmart, Velocity Pharma and Rugby.
The Centers for Disease Control and Prevention also issued warnings in 2023 after investigating an outbreak of Pseudomonas aeruginosa associated with contaminated eye drops and artificial tears.
Pseudomonas aeruginosa is a drug-resistant form of bacteria.
During that outbreak, the CDC warned consumers not to use EzriCare Artificial Tears, Delsam Pharma’s Artificial Tears and Delsam Pharma’s Artificial Ointment.
The current Clear Eyes action involves a different product and has been classified by the FDA as presenting a risk in which serious adverse health consequences are considered remote.
Consumers checking their Clear Eyes Maximum Itchy Eye Relief should compare the bottle information with the affected lot code, expiration date and National Drug Code identified in the FDA enforcement report.
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