Alcon Laboratories recalls Systane Lubricant Eye Drops due to potential fungal contamination, sparking health concerns nationwide.
At a Glance
- One lot of Systane Lubricant Eye Drops Ultra PF recalled due to fungal contamination
- Recall initiated after consumer reported foreign material in a sealed vial
- No adverse reactions reported, but potential risk of eye infections exists
- Consumers advised to stop using affected product and return for refund or replacement
- Recall conducted with FDA knowledge as a precautionary measure
Alcon Laboratories Takes Swift Action
In a move that underscores the importance of consumer safety, Alcon Laboratories has issued a voluntary nationwide recall of one lot of Systane Lubricant Eye Drops. The recall, announced on December 21, 2024, and published by the FDA on December 23, 2024, affects the Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101). This action comes in response to a consumer report of foreign material found in a sealed single-use vial, which was subsequently identified as fungal matter.
The affected product, intended for temporary relief of burning and irritation caused by dry eye, is packaged in a green cardboard box containing 25 sterile, single-use plastic vials. It can be identified by NDC 0065-1432-06 or UPC 300651432060, with an expiration date of September 2025. The eye drops were distributed nationwide through retail and internet outlets, making this recall a matter of national concern.
A popular brand of eye drops is now being recalled nationwide due to a possible fungal contamination. Alcon Laboratories in Texas is voluntarily recalling Systane Lubricant Eye Drops Ultra P-F, the Food and Drug Administration announced.
https://t.co/hSFv7TQzq1— WXYZ Detroit (@wxyzdetroit) December 28, 2024
Potential Health Risks and Precautions
While no adverse reactions have been reported thus far, the recall serves as a precautionary measure due to the potential risk of eye infections from fungal contamination. The FDA has emphasized the severity of these potential risks, stating, “If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients.”
Consumers in possession of the affected lot are strongly advised to discontinue use immediately and return the product for a refund or replacement. Alcon Laboratories is actively notifying distributors and customers, arranging for product replacement, and advising retailers to discard any remaining stock of the recalled product.
Company Response and Investigation
An Alcon spokesperson has stated that the company is conducting the recall out of an “abundance of caution.” The investigation into the contamination is ongoing, but initial findings suggest that this may be an isolated incident. The company is working closely with the FDA to address the issue and ensure consumer safety.
“An Alcon spokesperson said that investigation of the contamination is still ongoing, however, the foreign material report appears to be an isolated incident.” – Alcon spokesperson
For those with questions or concerns, Alcon Laboratories has set up a dedicated hotline at 1-800-241-5999. Consumers who have experienced any adverse reactions are encouraged to report them to their healthcare provider and the FDA’s MedWatch Adverse Event Reporting program.
Context and Recent History
This recall comes in the wake of several other eye drop recalls that occurred in 2023 due to bacterial contamination, highlighting the ongoing challenges in maintaining the sterility of ophthalmic products. The incident serves as a reminder of the importance of rigorous quality control measures in the pharmaceutical industry, particularly for products applied directly to sensitive areas like the eyes.
As the investigation continues, consumers are urged to remain vigilant and check their eye drop products against the recall information. The swift action taken by Alcon Laboratories and the FDA demonstrates a commitment to public health and safety, even in the absence of reported adverse events. This proactive approach to product safety is crucial in maintaining consumer trust and preventing potential health risks.
