The Swiss-American pharmaceutical company Alcon Laboratories is recalling one lot of its Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go. According to the FDA, the company issued the recall after identifying a fungal contaminant in the product.
Systane Lubricant Eye Drops are marketed to help with the burning and itching associated with mild cases of dry eye. The product is available over-the-counter and without a prescription. Alcon distributed the recalled product to distributors and retailers throughout the United States. Customers would have been able to find the product at retail stores and through online retailers. The primary active ingredients in the eye drops are polyethelene glycol 400 0.4% and propylene glycol 0.3 %.
Alcon announced the recall four days before Christmas, specifying the affected lot number as 10101 with a UPC of 300651432060 and an NDC of 0065-1432-06. The recall applies only to the 25-count packages of on-the-go Systane Lubricant Eye Drops from the specified lot. The product is packaged in a green cardboard box with pink and white lettering. Along with the product name, the label reads, “preservative-free dry eye relief.” The recalled lot has an expiration date of September, 2025, and customers can find both the lot number and the expiration date on the bottom of the box and stamped on the single-use vials.
Thus far, Alcon has not received any reports of injury or illness linked to use of the recalled eye drops. The company discovered the contamination when a customer notified them of foreign particles in one vial of the on-the-go drops. Testing then identified the foreign particulate as fungal. Alcon has not disclosed the type of fungus identified in the recalled product, but they say that use of eye drops contaminated with fungi could cause an eye infection. In rare cases, such an infection could compromise vision or, in the most extreme instances, cause death. Very young children, the elderly, and people with compromised immune systems are typically the most at risk for severe infection.
Alcon advises customers to cease use of the recalled product immediately. Customers and distributors can return Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go (Lot # 10101) to the point of purchase for a full refund or replacement.
Anyone with questions or concerns about the recall can contact Alcon Laboratories at 1-800-241-5999. They are available from 7:30 a.m. to 6:00 p.m. (CST), Monday through Friday.
Patients and health care providers can report any new adverse health events related to using Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count through the FDA’s MedWatch Online Voluntary Reporting Form.
If you or a loved one has suffered an injury or adverse health outcome linked to using contaminated eye drops, we urge you to get in touch with our team. It’s vital that the liable parties be held accountable for their negligence to prevent the further distribution of dangerous medications to customers in the United States. Our experienced attorneys at TruLaw are prepared to learn about your story and help you begin building a case for just compensation. Contact us today or try out our free Instant Case Evaluation ℠ to get started.