A to remind of almost 40,000 bottles of eye drops has been classified as the second highest risk level, indicating that use of the product may pose a risk to human health.
The FDA is considered a Class II recall of Clear Eyes Maximum Itchy Eye Relief, which is “a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health effects or where there is a potential for serious adverse health effects are minor.’
The recall of 39,060 bottles was originally issued on July 29 due to a “lack of assurance of sterility,” meaning there could be potential contamination with harmful particles, materials or bacteria in the product.
The recall affects over-the-counter 15ml bottles, which were distributed nationally by New York-based Prestige Brands Holdings.
The product has an expiration date of September 30, 2027 and lot number 2552A.
Consumers in possession of the eye drops should immediately stop using them as, if contaminated, they may cause an infection or damage vision.
The FDA did not specify whether the droplets tested positive for contamination, what the contamination might be or how they could have become contaminated.
No illnesses or injuries have been confirmed in connection with this recall.
The original recall of 39,060 bottles originally took place on July 29 due to a lack of assurance over sterility, meaning there could be potential contamination in the product (stock image)
A similar eye drop recall was issued last month for more than 12 million products, also due to fears of contamination.
Manufacturer Rohto has issued the warning for six of its over-the-counter eye drops, partly due to a ‘lack of certainty about sterility’.
The eye drops were sold nationally in 0.4 fl oz bottles with blue, red, green or black lids. One of the drops also comes in a pink bottle with a black lid.
They were sold individually or in a pack of two and have a best before date of August 2028.
The eye drops in the recall were Rohto Cooling Eye Drops ALL-IN-ONE, Max Strength, Optic Glow, Digi Eye, Dry Aid and Cool Relief.
Each contains medications used to relieve eye redness, inflammation, or other problems.
It contains 12 million boxes of eye drops. It was not clear how many bottles were in each box.
To date, no illnesses or injuries have been reported related to the recalls.
One of the largest eye drop recalls occurred in 2023, after eye drops made in India were found to be contaminated with a deadly bacteria. A total of 81 patients became ill, 18 suffered permanent blindness and four died.
