An urgent recall has been issued for eyedrops contaminated with a fungus that could cause blindness or even death.
Alcon Laboratories, based out of Fort Worth, Texas, is voluntarily recalling one lot of its Systane Lubricant Eye Drops Ultra PF that is used to relieve dry, irritated eyes.
The affected product involves boxes of single ‘on-the-go’ vials, sold in 25 packs, which were distributed nationwide to retail and internet outlets, including Walgreen, CVS and Target.
It is packaged in a cardboard carton containing with lot number 10101 and an expiration date of September 2025.
Alcon Laboratories launched an investigation after a consumer reported ‘foreign material’ inside a sealed single-use vial. The material was confirmed to be fungal in nature.
The FDA warns that fungal contamination in eye products can cause serious eye infections.
If left untreated, these infections may result in partial vision loss, blindness, or, in rare cases, become life-threatening for immunocompromised individuals.
Fungal contamination in eye drops can lead to fungal keratitis, a severe infection of the cornea that can cause vision loss or blindness due to scarring and corneal damage.
In the most extreme cases, the infection can spread to other parts of the body, including the bloodstream.
To date, Alcon Laboratories says it has not received any reports of adverse events related to this recall.
The FDA says the product can be identified by the green and pink carton design, presence of ‘Systane’ and ‘UltraPF’ brand names on the front of the carton, and the ’25 vials’ package size.
Consumers that have the recalled eye drops are instructed to should stop using them immediately and return to the place of purchase for a replacement or refund.
If they have experienced any problems that may be related to using this drug product, they should contact their physician or healthcare provider.
Meanwhile, Alcon Laboratories is notifying all of its distributors and customers and is arranging for replacement of all recalled products.
The FDA notes that distributors or retailers should discard any remaining stock of the Systane eyedrops.
Last year, it was believed that contaminated EzriCare Artificial Tears triggered more than 50 eye infections across 11 states.
All patients were infected with Pseudomonas aeruginosa – a drug-resistant bacterial strain that usually spreads in hospitals.
CDC investigators found all of the patients had used EzriCare Artificial Tears before they fell ill, and an investigation was launched to find if the products were contaminated.
An analysis from earlier this year found the FDA had recalled 133 over-the-counter CVS medicines over the last decade, or about one a month.
That was more than twice as many as its competitor Walgreens, which had 70 recalls over the same period, and three times more than Walmart, which had 51 recalls.
