Urgent recall of eye drops in the US due to potentially fatal mold contamination
An emergency recall has been issued for eye drops contaminated with a fungus that can cause blindness or even death.
Alcon Laboratories, based in Fort Worth, Texas, is voluntarily recalling a batch of its Systane Lubricant Eye Drops Ultra PF, used to relieve dry, irritated eyes.
The product concerned concerns boxes containing single ‘on-the-go’ bottles, sold in 25 packs, which distributed nationally to retail and online retailers including Walgreen, CVS and Target.
It is packaged in a cardboard box with lot number 10101 and an expiry date of September 2025.
Alcon Laboratories initiated an investigation after a consumer reported “foreign material” in a sealed, single-use vial. The material was confirmed to be fungal in nature.
The FDA warns that mold contamination in eye products can cause serious eye infections.
If left untreated, these infections can lead to partial vision loss, blindness, or, in rare cases, become life-threatening for individuals with weakened immune systems.
Fungal contamination in eye drops can lead to fungal keratitis, a serious infection of the cornea that can cause vision loss or blindness due to scarring and damage to the cornea.
An emergency recall has been issued for eye drops because the product may cause a fatal fungal infection, which can lead to blindness
Systane Lubricant Eye Drops Ultra PF is used to relieve dry, irritated eyes
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 its green and pink cardboard design, the presence of the brand names “Systane” and “UltraPF” on the front of the box, and the package size of “25 vials.”
Consumers who have the recalled eye drops are instructed to immediately stop using them and return to the place of purchase for a replacement or refund.
If they have experienced any problems that may be related to the use of this medicine, they should contact their doctor or healthcare provider.
In the meantime, Alcon Laboratories is notifying all its distributors and customers and arranging for the replacement of all recalled products.
The FDA notes that distributors or retailers should discard any remaining stock of Systane eye drops.
Last year, contaminated EzriCare artificial tears were believed to cause more than 50 eye infections in 11 states.
All patients were infected with Pseudomonas aeruginosa, a drug-resistant strain of bacteria that commonly spreads in hospitals.
CDC investigators found that all patients had used EzriCare artificial tears before becoming ill, and an investigation was launched to determine whether the products were contaminated.
An analysis from earlier this year found that the FDA had recalled 133 over-the-counter CVS medications over the past decade, or about one per month.
That was more than twice as many as competitor Walgreens, which had 70 recalls in the same period, and three times as many as Walmart, which had 51 recalls.
The reasons for CVS’s recalls included medications contaminated with bacteria, mold growth in factory fans, peeling paint and barefoot workers in factories and pills containing incorrect doses.
Own-brand eye drops were the CVS products most likely to be recalled over the past decade, followed by own-brand constipation medications – such as magnesium citrate tablets – and drugs to treat colds and flu.