A popular brand of eye drops has been recalled

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Popular brand of eye drops It is being called nationwide Due to potential contamination, which may cause damage to eyesight, according to the Food and Drug Administration (FDA).

The FDA announced Monday that Texas-based Alcon Laboratories was voluntarily recalling one lot of “Systane Lubricant Eye Drops Ultra SPF, Single Vials On-the-Go” because the products may be contaminated with fungi.

The company reported a complaint from a consumer that a “foreign substance” was found inside a sealed disposable vial and determined the substance was “fungal in nature.”

It is known that fungal contamination in eye productso May cause eye infections, The Food and Drug Administration said.

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Mention eye drops

The Food and Drug Administration (FDA) announced Monday that Alcon Laboratories, based in Texas, is voluntarily recalling one lot of “Systane Lubricant Eye Drops Ultra SPF, Single Vials On-the-Go” because the products may be contaminated with lubricant. (Food and Drug Administration (FDA)/Fox News)

If an infection occurs, the FDA said it may be vision-threatening and, in very rare cases, life-threatening 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, On-the-Go Single Vials, 25 Count, and that it is limited to lot number 10101, expiration date 09/2025.

The Food and Drug Administration explained in a press release that the product can be identified by the green and pink carton design, the presence of the trade names “Systane” and “ULTRA PF” on the front of the carton, and the package size of “25 vials.”

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Picture of evocative eye drops

Systane Lubricant Eye Drops Ultra SPF, Single Vials On-the-Go has been recalled because the products may be contaminated with fungi, according to the US Food and Drug Administration. (Food and Drug Administration (FDA)/Fox News)

Many of the potentially affected eye drops were also distributed nationwide to retail outlets and the Internet.

Consumers with the recalled eye drops are urged to stop using them immediately and return them to the place of purchase for a replacement or refund, the FDA said.

Distributors or retailers with the recalled eye drops are also urged to dispose of any remaining stock of the contaminated product.

Alcon Laboratories also notifies its distributors and customers by letter, email and/or phone calls and arranges for the replacement of all recalled products.

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Image of an eye drop product recall

Alcon Laboratories issued the recall after a consumer complained about the presence of a “foreign substance” 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 were sold at a price CVS and Walmart stores nationwide It was recalled after the FDA found a “lack of sterility assurance” at the manufacturing facility.

The image of the recalled eye drops has been enlarged

Alcon Laboratories in Texas is voluntarily recalling Systane Lubricant Eye Drops Ultra PF after a consumer complaint of observable foreign matter inside a sealed vial. (Food and Drug Administration (FDA)/Fox News Latino)

The four affected products, which are supposed 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 nationally to wholesalers, retailers and through product distributor Walmart , CVS and AACE Pharmaceuticals

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In November 2023, Kilitch Healthcare India Limited voluntarily recalled 27 eye drops, all of which are on the US Food and Drug Administration’s (FDA) list of generic products that may be contaminated with bacteria, posing a risk of eye infection and vision loss.

None of the above recalls have been linked to outbreaks of antibiotic-resistant bacteria Pseudomonas aeruginosa Associated with ophthalmic products by Global Pharma Healthcare.

Fox News Digital’s Daniella Genovese contributed to this report.



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