Nearly 40,000 bottles of eye drops have been recalled in the United States over fears they were not properly sterilised. The US Food and Drug Administration (FDA) issued a product recall notice for 39,060 bottles of the eye drops manufactured by Prestige Brands Holdings.
Voluntary recall by manufacturer
The company, based in Tarrytown, New York state, voluntarily recalled a batch of its products. The affected product is ‘Clear Eyes Maximum Itchy Eye Relief’, sold in 0.5 fl oz (15ml) bottles and stocked by multiple major supermarkets.
Only the ‘2552A’ batch is affected, which includes bottles bearing the expiry date of September 30, 2027. The FDA notice stated: “Lack of assurance of sterility. The recall is due to potential contamination.”
Class II recall classification
It is a ‘Class II’ recall, the middle tier of product recalls in terms of ‘the relative degree of health hazard’ posed by the product. Class II means the administration has declared a ‘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’.
The eye drops are sold across the US, with big name stores such as Walmart, Target, and Dollar General stocking the product. The recall was issued late last month.
