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Alcon Laboratories recalls popular Systane eye drops due to potential fungal contamination, prompting nationwide alert.
At a Glance
- Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) recalled nationwide
- Recall initiated after consumer reported foreign material, identified as fungal, in sealed vial
- No adverse reactions reported, but fungal contamination poses serious eye infection risk
- Consumers advised to stop using affected product and seek refund or replacement
- Recall is voluntary and affects only one lot, number 10101
Alcon Laboratories Initiates Nationwide Recall
In a move that has caught the attention of eye care professionals and consumers alike, Alcon Laboratories has announced a voluntary nationwide recall of one lot of its popular Systane Lubricant Eye Drops. The recall, which affects the Ultra PF, Single Vials On-the-Go, 25 count product with lot number 10101, comes after a consumer reported finding a foreign substance in a sealed vial, later identified as fungal contamination.
The Food and Drug Administration (FDA) published the recall notice on December 23, 2024, following Alcon’s announcement on December 21. This swift action underscores the seriousness with which both the company and regulatory bodies are treating the potential health risk. While no adverse reactions have been reported thus far, the recall serves as a precautionary measure due to the significant dangers posed by fungal contamination in ophthalmic products.
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 Identification of Affected Products
The FDA has emphasized the gravity of the situation, stating, “If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients.” This stark warning highlights the need for consumers to take this recall seriously and act promptly if they have purchased the affected product.
“Fungal contamination of an ophthalmic product is known to potentially cause eye infections” according to the recall notice.
Consumers can identify the recalled product by its green and pink carton design, prominently displaying the “Systane” and “ULTRA PF” brand names. The package contains 25 sterile, single-use plastic vials and is identifiable by NDC 0065-1432-06 or UPC 300651432060. It’s crucial to note that the affected lot expires in September 2025, meaning many consumers may still have this product in their possession.
Consumer Action and Company Response
Alcon Laboratories is urging consumers who have purchased the recalled eye drops to stop using them immediately. The company is offering refunds or replacements for affected products. This proactive approach aligns with Alcon’s commitment to consumer safety, as evidenced by a company spokesperson’s statement that the recall was initiated out of an “abundance of caution.”
“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
Consumers with questions or concerns are encouraged to contact Alcon Laboratories at 1-800-241-5999 during specified hours. Additionally, any potential adverse reactions should be reported to a healthcare provider and can be submitted to the FDA’s MedWatch Adverse Event Reporting program online. This comprehensive approach to consumer safety and communication demonstrates Alcon’s commitment to addressing the issue thoroughly and transparently.
As this recall unfolds, it serves as a reminder of the importance of vigilance in consumer health products. The swift action taken by Alcon Laboratories and the FDA’s involvement underscore the robust safety measures in place to protect public health, even as they highlight the ongoing challenges in maintaining product safety in the pharmaceutical industry.