A Systane product was found to have been contaminated.
A popular brand of eye drops has been recalled in the US after a vial was found contaminated with fungus.
The Systane Lubricant Eye Drops Ultra PF – which stands for preservative-free – have been marketed as offering “fast-acting hydration and lasting relief.”
Major US media outlets reported on the recall notice on Wednesday, even though the Texas-based Alcon Laboratories notified the federal government of the voluntary recall on Saturday, and the Food and Drug Administration posted the recall notice on Monday.
According to Alcon, the recall followed “a consumer complaint of foreign material observed inside a sealed single-use vial,” which was determined to be “fungal in nature.”
Fungal eye infections can result in loss of vision and have the potential to be fatal in individuals with compromised immune systems. Alcon said it has yet to receive any reports of adverse effects from the affected eye drops.
The recall affects Lot 10101, with expiration date of September 2025. They were sold in boxes of 25 single-use vials to major retailers such as Target, Kroger, Walmart, and Walgreens, as well as online.
The FDA has instructed anyone who may have purchased a recalled package to stop using it immediately and return it to the seller for replacement or refund. Anyone adversely affected by the drops should report the problem to the MedWatch Adverse Event Reporting program, whether online, by mail, or by fax, the agency said.
Image credit: Ion Fet
