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Systane Eye Drops Under Caution: Potential Fungal Contamination Threat Emerges

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Recall: Systane eye drops may have possible 'fungal contamination' risk


WASHINGTON — A recall has been issued for Systane eye drops due to potential fungal contamination, the Food and Drug Administration (FDA) announced. The recall affects one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, following a consumer complaint regarding foreign material found inside a sealed vial.

Alcon Laboratories, the Texas-based manufacturer, confirmed the material was determined to be fungal in nature. Although there have been no reported adverse reactions linked to the recall, the FDA warns that fungal contamination poses serious health risks, particularly eye infections that could threaten vision, especially for immunocompromised individuals.

These eye drops are generally utilized for temporary relief of burning and irritation related to dry eye symptoms. They are packaged in 25-count boxes and are identified by lot number 10101, with an expiration date set for September 2025.

The potentially contaminated eye drops were distributed across the country at various retail locations, including Publix, as well as online platforms. Consumers who possess the affected product are advised to cease use immediately and return it for a refund or replacement. Those facing any related health issues should consult a healthcare provider promptly.

Alcon Laboratories is engaging in efforts to notify distributors and customers about this recall. For further inquiries, consumers can reach Alcon at 1-800-241-5999 during weekdays from 7:30 AM to 6:00 PM Central Time. Any adverse reactions can also be reported to the FDA’s MedWatch program through their website, by mail, or via fax.