FDA Recalls Single Lot of Systane Lubricant Eye Drops Ultra PF Due to Possible Fungal Contamination

by drbyos

Systane Eye Drops Voluntarily Recalled Due to Fungal Contamination

A recent voluntary recall issued by the U.S. Food and Drug Administration (FDA) affects a batch of Systane brand eye drops, specifically the Systane Lubricant Eye Drops Ultra PF Single Vials On-the-Go variety. This recall stems from a customer’s report of visible foreign material inside a sealed vial, which was confirmed to be fungal.

Details of the Recall

The affected lots are identified by lot number 10101 and expire in September 2025. These specific eye drops are designed to alleviate symptoms of dry eye and were sold in packages of 25 on-the-go single-use vials.

Systane eye drops were recalled after possible fungal contamination.

FDA

Risk of Fungal Contamination

Fungal contamination in eye products poses serious health risks. According to the FDA, infections caused by such contamination can threaten vision and, in rare cases, be life-threatening for individuals with compromised immune systems.

Protecting Your Eyes

For those who might own the affected lot of Systane eye drops, it is crucial to discontinue use immediately and discard them safely. The manufacturer, Alcon Laboratories, suggests contacting them at 1-800-241-5999 for more information or assistance.

Reporting Issues

Any adverse reactions or quality concerns regarding this product should be reported to the FDA’s MedWatch Adverse Event Reporting program. Consumers can do so online, via mail, or by fax.

Recalls of Eye Drops

This recall is not isolated, as the medical community faced similar issues in 2023 when bacterial contamination led to recalls of numerous eye drop products. Such incidents highlight the importance of stringent quality control in the medical industry.

For more information on these and other recalls, the FDA maintains an updated list on its website. Staying informed can help consumers make informed decisions about their health and ensure safe medication use.

Advice for Consumers

Here are some steps consumers can take to protect themselves from contaminated eye products:

  • Check the expiration date and lot number on the packaging before use.
  • Report any unusual product appearance or complaints to the manufacturer or FDA.
  • Use new, sterile eye drops for each application to maintain hygienic standards.

Proactive measures can significantly reduce the risk of contamination and ensure safe eye care practices.

Conclusion

The voluntary recall of Systane eye drops underscores the importance of vigilance in healthcare product safety. Consumers are encouraged to stay informed about product recalls and follow proper handling procedures to protect their health.

If you have the recalled product, it is imperative to stop using it and contact Alcon Laboratories for instructions on safe disposal and potential reimbursement.

For updates on similar issues and other health-related news, subscribe to our newsletter to stay informed.

Join the conversation below and share your thoughts on this health alert. If you have any questions or need further assistance, feel free to leave a comment!

Related Posts

Leave a Comment