Alcon Recalls Systane Ultra PF Lot Over Potential Fungal Contamination
Alcon Laboratories has announced a voluntary recall of Lot 10101 of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count. The recall follows a consumer complaint regarding foreign material observed inside a sealed single-use vial, which was determined to be fungal in nature.
Risk of Fungal Contamination
In a risk statement, Alcon explained:
“Fungal contamination of an ophthalmic product is known to potentially cause eye infections. If an infection occurs, it may be vision-threatening, and in very rare cases potentially life-threatening in immunocompromised patients.”
While no adverse events have been reported to date, the recall is being conducted as a precautionary measure.
Product Identification
The affected product is intended for temporary relief of burning and irritation in individuals with dry eye symptoms. It is packaged in a cardboard carton containing 25 sterile, single-use LDPE plastic vials of preservative-free solution.
Key Identification Details
• Lot Number: 10101
• Expiration Date: 2025/09
• Packaging Design: Green and pink carton featuring the "Systane" and "ULTRA PF" brand names
• Distribution: Nationwide to retail and online outlets
Actions for Consumers and Distributors
For Consumers
Alcon advises consumers to:
• Stop using the product immediately.
• Return it to the place of purchase for a replacement or refund.
• Contact Alcon Laboratories at 800-241-xx with any questions.
For Distributors and Retailers
Distributors and retailers are instructed to:
• Discard any remaining stock of the affected lot.
• Notify customers about the recall as directed by Alcon.
Reporting and Support
Adverse reactions or quality problems associated with the product can be reported to the FDA’s MedWatch Adverse Event Reporting program via their website or by mail or fax.
Alcon has contacted distributors and customers through letters, emails, and phone calls to arrange replacements for the recalled products. This action underscores Alcon’s commitment to consumer safety and regulatory compliance.
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