WASHINGTON — Systane eye drops are under recall due to a possible fungal contamination, according to the Food and Drug Administration.
The FDA announced Monday that Texas-based company Alcon Laboratories was voluntarily recalling one lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go following a consumer complaint of “foreign material observed inside a sealed single use vial.” Alcon determined the material to be “fungal in nature,” according to the recall alert.
While there have been no adverse reactions reported in relation to the recall, the affected product could pose serious health risks to consumers. Fungal contamination could cause eye infections that may be “vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients,” the FDA said.
The eye drops are typically used for temporary relief of burning and irritation for people with dry eye symptoms. They come in single vials sold in 25-count packages and they are identified with lot number 10101. The recalled products have an expiration date of September 2025.
The eye drops were distributed nationwide to retail, including Publix, and internet outlets, according to the FDA.
Consumers who have the recalled eye drops are urged to stop using them immediately and return the product to their place of purchase for a refund or replacement. Anyone experiencing any problems related to the recall should contact their doctor or healthcare provider.
Alcon is actively notifying distributors and customers about the recall. For questions, consumers can contact Alcon at 1-800-241-5999 on weekdays between 7:30 AM and 6:00 PM Central Time.
Adverse reactions can be reported to FDA’s MedWatch program online, by mail or by fax.
