Alcon Laboratories, situated in Fort Worth, Texas, and a subsidiary of the Swiss company Alcon Inc., specializing in eye care devices, is issuing a recall for a specific batch of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, comprising 25 vials.
The recall comes after the US Food and Drug Administration (FDA) reported the discovery of a foreign material in a sealed single-use vial, identified as a fungus. This recall at the consumer level pertains exclusively to lot number 10101, with an expiration slated for September 2025.
This product is designed to provide temporary relief from the burning and irritation associated with dry eyes. The recalled batch can be recognized by its distinctive green and pink packaging. It is sold in a cardboard box containing 25 sterile, single-use plastic vials filled with a preservative-free eye solution, marked with NDC 0065-1432-06 and UPC 300651432060.
The distribution of these products spanned nationwide, reaching both retail and online outlets. The recall was initiated after a consumer reported a foreign substance within a vial, which was confirmed to be fungal contamination. Such contamination poses a risk of eye infection, potentially impairing vision and, in extremely rare cases, could be life-threatening for individuals with compromised immune systems.
Despite the recall, Alcon Laboratories has not received any reports of adverse effects related to this issue. Consumers are advised to discontinue use immediately and return the product to the point of purchase to receive a replacement or refund.
The material has been provided by InstaForex Company -
www.instaforex.com
