39,060 bottles of eye drops recalled in the US

The US Food and Drug Administration (FDA) has notified consumers of a company-initiated recall of 39,060 bottles of eye drops due to potential contamination concerns.

The recall affects bottles of Clear Eyes Maximum Itchy Eye Relief with the lot number 2552A and an expiry of 30 September 2027. The product is distributed by Prestige Brands Holdings. The product does not have a UK distributor.

Explaining the reason for the recall, the FDA states that there is a “lack of assurance of sterility. The recall is due to potential contamination.”

The recall is categorised as class II – a form of classification that the FDA uses to indicate the severity of the health hazard posed by the recalled product.

Class II relates to products where use of the product “may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.”

The recall of Clear Eyes Maximum Itchy Eye Relief follows another FDA recall of more than three million bottles of eye drops in the US in March that also related to sterility concerns.

The March recall involved eight different eye drop products distributed by KC Pharmaceuticals. Full lot numbers and expiry dates of the affected products are on the FDA website.