A lot of Systane Lubricant Eye Drops Ultra PF has been voluntarily recalled due to concerns of fungal contamination, posing potential health risks to users. The recall was initiated by Alcon Laboratories after a consumer complaint revealed the presence of foreign material in a sealed single-use vial, later confirmed to be fungal in nature. The announcement was published by the Food and Drug Administration (FDA) earlier this week.
The recalled product involves single-use vials packaged in green and pink cartons labeled "Systane" and "Ultra PF." The affected lot is numbered 10101, with an expiration date of September 2025. The eye drops, designed to alleviate dry and irritated eyes, were distributed across the United States through major retailers and online platforms, including Publix, CVS, Walgreens, and Target.
Although no adverse reactions have been reported to date, fungal contamination in eye products can lead to severe health complications, including fungal keratitis, a corneal infection that may cause vision loss or blindness if untreated. In rare cases, the infection can spread to the bloodstream, particularly in immunocompromised individuals, making the contamination potentially life-threatening.
The FDA's recall notice emphasized that users of the recalled eye drops should immediately cease usage and return the product to the retailer for a refund or replacement. Retailers and distributors have been instructed to remove any remaining stock of the affected products to prevent further distribution.
The recall follows Alcon Laboratories' internal investigation, which confirmed the contamination after the consumer complaint. The company is working to notify retailers and customers about the recall through direct communication, including letters, emails, and phone calls. Customers experiencing any issues or adverse reactions related to the recalled product are encouraged to report them to the FDA's MedWatch Adverse Event Reporting program.
This incident highlights the ongoing challenges in ensuring the safety and quality of over-the-counter medical products. Last year, a similar case involving EzriCare Artificial Tears led to more than 50 infections across 11 states, with the Centers for Disease Control and Prevention (CDC) tracing the cases to Pseudomonas aeruginosa, a drug-resistant bacterial strain. The outbreak underscored the importance of rigorous quality control in manufacturing processes for pharmaceutical products.
Alcon Laboratories' recall comes amidst growing scrutiny of consumer health products. Over the past decade, the FDA has recalled numerous over-the-counter drugs and eye care products due to contamination concerns, with some cases linked to mold growth in factory ventilators and improper manufacturing practices.
Consumers who have used the affected Systane eye drops and are experiencing any symptoms or complications are advised to seek immediate medical attention. Healthcare providers remain vigilant about the risks of fungal infections caused by contaminated eye products, especially among vulnerable populations.