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The Guardian - US
The Guardian - US
Business
Marina Dunbar

40,000 bottles of eye drops across the US recalled over issues with sterility of product

FDA seal.
The FDA classified the action as a Class II recall, defined on the agency’s website as a moderate-risk situation. Photograph: José Luis Magaña/AP

Nearly 40,000 bottles of eye drops are being pulled from store shelves across the US over concerns about potential contamination, according to the Food and Drug Administration (FDA).

Prestige Brand Holdings, based in Tarrytown, New York, has voluntarily recalled 39,060 bottles of Clear Eyes Maximum Itchy Eye Relief eye drops because of a “lack of assurance of sterility”, an FDA enforcement report states. The FDA classified the action as a Class II recall, defined on the agency’s website as a moderate-risk situation “in which 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”.

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