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A popular brand of eye drops being remembered across the country According to the Food and Drug Administration (FDA), due to potential contamination, which could cause vision damage.
On Monday, the FDA announced that Texas-based Alcon Laboratories is voluntarily recalling a batch of “Systane Lubricant Eye Drops Ultra SPF, Single Vials On-The-Go” because the products may be contaminated with fungus.
The company reported a consumer complaint that a “foreign material” was found inside a sealed single-use vial and it was determined that the material was “fungal in nature.”
Known fungal contamination in ophthalmic productso Potentially cause eye infections, The FDA said.
Eye products sold at Walmart, CVS may pose risk of infection
The Food and Drug Administration (FDA) announced Monday that Texas-based Alcon Laboratories is voluntarily recalling a batch of “Systane Lubricant Eye Drops Ultra SPF, Single Vials On-The-Go” because the product may be contaminated with molasses. Can happen. (Food and Drug Administration (FDA) / Fox News)
If an infection does occur, the FDA said it could be vision-threatening, and in very rare cases, potentially life-threatening in immunocompromised patients.
To date, the FDA stated that Alcon Laboratories has not received any reports of adverse events related to this recall.
The FDA says the affected product includes Systane Lubricant Eye Drops Ultra PF, Single Vials On-The-Go, 25 Count and is limited to lot number 10101, expiration date 2025/09.
The FDA explained in a press release that the product can be identified by the green and pink carton design, the presence of the “Systen” and “Ultra PF” brand names on the front of the carton, and the “25 vials” package size.
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According to the FDA, “Systane Lubricant Eye Drops Ultra SPF, Single Vials On-The-Go” has been recalled because the product may be contaminated with fungus. (Food and Drug Administration (FDA) / Fox News)
A large number of potentially affected eye drops were also distributed to retail and Internet outlets across the country.
The FDA said consumers who have the recalled eye drops are urged to stop using them immediately and return them to the place of purchase for replacement or refund.
Distributors or retailers who have the recalled eye drops are also being urged to discard any remaining stock of the tainted product.
Alcon Laboratories is also notifying its distributors and customers via letter, email and/or phone call and arranging for replacement of all recalled products.
Alcon Laboratories issued the recall after a consumer complained that “foreign material” was found in a sealed vial of eye drops. (Food and Drug Administration (FDA) / Fox News)
This latest recall comes as several eye products have been removed from shelves over the past year due to the potential risk of infection.
In February, eye ointment products were sold CVS and Walmart stores nationwide These were recalled after the FDA discovered a “lack of sterility assurance” at the manufacturing facility.
Alcon Laboratories in Texas is voluntarily recalling Systane Lubricant Eye Drops Ultra PF following a consumer complaint of foreign material that could be seen inside a sealed vial. (Food and Drug Administration (FDA) / Fox News Latino)
The four affected products, which are intended to be sterile, are sold under the brand names Equate, CVS Health and AACE Pharmaceuticals, and their expiration dates range from February 2024 to September 2025. The products were distributed across the country through wholesalers, retailers and. Product Distributor, Walmart, CVS and AACE Pharmaceuticals Inc.
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In November 2023, Kilich Healthcare India Ltd. voluntarily recalled 27 eyedrops, all of which were listed on the FDA’s rolling list of products that may be contaminated with bacteria, leading to a risk of eye infections and vision loss. It is possible
None of the above recalls are linked to outbreaks of antibiotic-resistant bacteria pseudomonas aeruginosa Associated with ophthalmic products by Global Pharma Healthcare.
Fox News Digital’s Daniela Genovese contributed to this report.
