Nearly 40,000 bottles of drops for itchy and dry eyes were recalled beginning last month because of “potential contamination,” according to the Food and Drug Administration.
The voluntary recall of Clear Eyes Maximum Itchy Eye Relief 0.5-fluid-ounce bottles began July 29 and was issued by Prestige Consumer Healthcare, which is the parent company of Clear Eyes, because of a “lack of assurance of sterility,” according to a notice posted by the FDA.
The recall was due to a potential for contamination identified during the manufacturing process, according to Phil Terpolilli, a spokesman for Prestige Consumer Healthcare, and the product was not confirmed to be contaminated.
“We initiated this voluntary recall out of an abundance of caution and our commitment to providing consumers with safe, high-quality products,” Terpolilli wrote in an email, adding that no serious adverse events have been reported as of Monday.
The FDA has listed the recall as Class II, which means the use or exposure to a product “may cause temporary or medically reversible” health issues and is unlikely to cause serious health consequences. The expiration date of the recalled drops is Sept. 30, 2027.
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