The company Alcon Laboratories, maker of a popular brand of eye drops, recalled some of its nationwide stock on Dec. 23, after discovering a fungal contamination in one of its products.
Alcon, the company behind the Systane eye drops brand, said it was recalling a single lot of its Systane Lubricant Eye Drops Ultra PF, in an announcement released by the Food and Drug Administration.
According to the FDA announcement, a consumer complained to the company about a “foreign material observed inside a sealed single-use vial.” Following an evaluation of the complaint by Alcon, the company determined the substance to be “fungal in nature.”
But, the FDA noted, “To date, Alcon Laboratories has not received any reports of adverse events related to this recall.”
An Alcon spokesperson told PEOPLE it is “conducting a voluntary recall of one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) distributed only in the United States following the discovery of foreign material inside a single, unused, plastic unit dose vial returned with a customer-reported complaint.
Investigation of this event is still ongoing; however, the presence of foreign material appears to be isolated to the single unit returned by a customer. To date, there are no adverse events related to this recall. However, out of an abundance of caution, Alcon has initiated a voluntary recall and notified the US FDA.”
The affected product is sold as 25 single-use sterile vials of solution, which consumers can use for temporary relief of burning eyes and irritation. But, per FDA’s recall announcement, a fungal contamination like those found in recalled products could cause eye infections that may be vision-threatening and, in rare circumstances, life-threatening for those who are immunocompromised.
Alcon said that Lot 10101 has an expiration date of 2025/09, and that the lot number and expiration dates are indicated on the product’s packaging. If a consumer has purchased the recalled product, the FDA advises they stop using the product immediately and return it to their point of purchase for a refund or replacement.
The company also noted that it was reaching out to its distributors to advise them to dispose of any of their remaining stock of the recalled products.
Kroger announced that its stores in Alabama, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina, Ohio, Tennessee, and Virginia were impacted by the recall. Fred Meyer, Ralphs, QFC, and Publix also said that their stores were affected.
Alcon spokesperson Steven Smith said that the company’s investigation was still underway, but noted that “the presence of foreign material appears to be isolated to the single unit returned by a customer,” NBC News reported.
He added that the company’s recall was done “out of an abundance of caution to prioritize consumer safety.”
In the statement to PEOPLE, the Alcon spokesperson said, “Our priority is ensuring the safety of our products while maintaining compliance with all regulatory bodies. ”
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