Nearly 40,000 bottles of Clear Eyes Maximum Itchy Eye Relief are being recalled nationwide after Prestige Consumer Healthcare raised a sterility concern.
Here's what to know
Distributed nationwide by Medtech Products, Clear Eyes Maximum Itchy Eye Relief sold in 0.5-fluid-ounce (15-milliliter) bottles was recalled by the New York-based Prestige Consumer Healthcare on July 29, according to CBS News.
The U.S. Food and Drug Administration notice described the issue as a "lack of assurance of sterility." The same notice added, "The recall is due to potential contamination."
That does not necessarily mean every bottle is contaminated, and no injuries have been reported to date, according to a Prestige spokesperson via NBC News.
"Although the affected 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," the spokesperson said in an email.
More background
This isn't the first eyedrop to be recalled this summer. Over 2,000,000 bottles of Prednisolone Acetate Ophthalmic Suspension eye drops were recalled in June due to suspected contamination by a foreign substance.
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Federal regulators labeled the action a Class II recall — a category the FDA says can involve products with "temporary or medically reversible adverse health consequences."
What's being done?
The most immediate step is the recall itself, which removes the affected bottles from the market and alerts consumers, retailers, and health professionals to the possible risk.
The next step is to stop using any recalled Clear Eyes Maximum Itchy Eye Relief bottles and carefully check the product packaging. Anyone who believes they may have the affected product should follow the manufacturer's or FDA's recall instructions and consider contacting a medical professional if they experience irritation or other symptoms after using the drops.
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