Systane Eye Drops Recall Due to Fungal Contamination Risk
A significant eye drop recall has been issued due to potential fungal contamination. This recall on eye drops affects thousands of users across the country who rely on these drops for daily eye care and dry eye relief. The recall specifically targets Systane Ultra lubricant eye drops, a popular brand of over-the-counter eye drops, with multiple lot numbers being recalled from the market.
Recall Details and Immediate Actions
Following an urgent consumer complaint, Alcon Laboratories has initiated a voluntary nationwide recall of Systane Lubricant Eye Drops Ultra PF. The recall specifically targets lot number 10101 with an expiration date of September 2025.
The recall was triggered after a customer discovered foreign material in a sealed single-use vial, which laboratory testing confirmed to be fungal in nature. The affected product can be identified by these specific characteristics:
Green and pink carton design
"Systane" and "ULTRA PF" branding on the front
25-count single-use vials package
NDC 0065-1432-06
UPC 300651432060
We urge consumers who have purchased these lubricant eye drops to stop using immediately and return them to their place of purchase for a full refund or replacement. The product was widely distributed through various retailers, including Publix, Amazon, Target, and Rite Aid.
For questions or concerns about this recall, consumers can contact Alcon Laboratories. Alcon Laboratories is actively notifying all distributors and customers through multiple communication channels, including letters, emails, and phone calls. The company has taken this step to prioritize consumer safety, although no adverse events related to this recall have been reported so far.
Health Risks and Safety Concerns
The FDA has issued serious warnings about the health implications of using contaminated ophthalmic products. These eye drops, which are meant to be sterile, pose a heightened risk because they bypass the body's natural defenses when applied directly to the eyes.
Potential Health Risks:
Severe eye infections
Partial vision loss
Complete vision loss
Eye irritation and inflammation
Potential life-threatening complications for immunocompromised individuals
The FDA has discovered concerning evidence during facility inspections, including positive bacterial test results from critical drug production areas and insanitary conditions. While Alcon Laboratories reports no adverse events related to this recall so far, the FDA encourages reporting any adverse reactions through their MedWatch Adverse Event Reporting program.
Conclusion
This eye drop recall serves as a crucial reminder about the importance of product safety. Alcon Laboratories' swift action through this voluntary recall demonstrates their commitment to consumer protection. Users of these eye drops should check their Systane Ultra lubricant eye drops against the recalled lot number 10101 with an expiration date of September 2025. Remember to stop using affected products and seek prompt medical attention if you notice any unusual symptoms.