Prestige Brands Holdings is voluntarily recalling 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief due to a lack of assurance of sterility. Prestige initiated the recall July 29. The FDA classified it as Class II on Aug. 14, meaning use of the product could cause temporary or medically reversible health consequences.
The recall affects 15-milliliter dropper bottles with lot number 2552A and an expiration date of Sept. 30, 2027, according to an Aug. 14 FDA enforcement report. The product, distributed nationwide, is made by Medtech Products, a Prestige Consumer Healthcare company based in Tarrytown, N.Y.
The recall is the latest in a string of ophthalmic sterility recalls this year. In March, K.C. Pharmaceuticals recalled more than 3 million eye drop bottles sold under store brands including CVS, Walgreens and Kroger over the same “lack of assurance of sterility” language. In July, Lupin Pharmaceuticals recalled 2.5 million bottles of prednisoLONE acetate ophthalmic suspension over a foreign substance.
At the Becker's 11th Annual IT + Revenue Cycle Conference: The Future of AI & Digital Health, taking place September 14–17 in Chicago, healthcare executives and digital leaders from across the country will come together to explore how AI, interoperability, cybersecurity, and revenue cycle innovation are transforming care delivery, strengthening financial performance, and driving the next era of digital health. Apply for complimentary registration now.
