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A popular brand of eye drops is being recalled across the country due to possible contamination, which can cause vision damage, according to the Food and Drug Administration (FDA).
On Monday, the FDA announced that Texas-based Alcon Laboratories was voluntarily recalling a single 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 determined that the material was “fungal in nature.”
Fungal contamination in eye products is known tor may cause eye infections, the FDA said.
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The Food and Drug Administration (FDA) announced Monday that Texas-based Alcon Laboratories is voluntarily recalling a single batch of “Systane Lubricant Eye Drops Ultra SPF, Single Vials On-the-Go” because the products may be contaminated with fun. (Food and Drug Administration (FDA) / Fox News)
If infection occurs, the FDA said it can be vision-threatening and, in very rare cases, potentially fatal in immunocompromised patients.
To date, the FDA said 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 09/2025.
The product can be identified by the design of the green and pink carton, the presence of the markings “Systane” and “ULTRA PF” on the front of the carton, and the package size of “25 vials,” the FDA explained in a statement press
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“Systane Lubricant Eye Drops Ultra SPF, Single Vials On-the-Go” have been recalled because the products may be contaminated with fungus, according to the FDA. (Food and Drug Administration (FDA) / Fox News)
The large quantity of potentially affected eye drops were also distributed nationwide to retail and Internet outlets.
Consumers who have the recalled eye drops are asked to stop using them immediately and return them to the place of purchase for a replacement or refund, the FDA said.
Distributors or retailers who have the recalled eye drops are also asked to discard any remaining stock of the contaminated product.
Alcon Laboratories is also notifying its distributors and customers by letter, email and/or phone call and is arranging for replacement of all recalled products.
Alcon Laboratories issued the recall after a consumer complained of a “foreign material” they 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 pulled from shelves over the past year due to the potential risk of infection.
In February, eye ointment products are sold at CVS and Walmart stores nationwide were recalled after the FDA discovered a “lack of assurance of sterility” at the manufacturing facility.
Alcon Laboratories of Texas is voluntarily recalling Systane Lubricant Eye Drops Ultra PF following a consumer complaint of foreign material that could be observed 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 have expiration dates ranging from February 2024 to September 2025. The products were distributed throughout the country to wholesalers, retailers and through the product distributor, Walmart, CVS and AACE Pharmaceuticals Inc.
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In November 2023, Kilitch Healthcare India Limited voluntarily recalled 27 eye drops, all of which are listed on the FDA’s continuing list of products that may be contaminated with bacteria, posing a risk of eye infection and vision loss .
None of the aforementioned recalls have been linked to the outbreak of antibiotic-resistant bacteria Pseudomonas aeruginosa related to Global Pharma Healthcare eye products.
Fox News Digital’s Daniella Genovese contributed to this report.
