The Food and Drug Administration (FDA) has issued a nationwide recall of a specific lot of Systane Lubricant Eye Drops Ultra PF due to potential fungal contamination. The recall, announced on December 23, applies to single-use vials sold in 25-count packages, following concerns raised by a consumer report.
Details of the Eye Drops Recall
The affected product, manufactured by Alcon Laboratories, carries the lot number 10101, UPC 300651432060, and expiration date of September 2025. Distributed widely across the United States through retailers like Target, Walmart, Walgreens, and online platforms, the eye drops are commonly used to alleviate symptoms of dry eye, such as burning and irritation.
The FDA and Alcon Laboratories confirmed that the fungal contamination stemmed from a consumer-reported issue involving the presence of “foreign material” in the vials. Subsequent investigations revealed that the material was fungal in nature.
Potential Health Risks
Fungal contamination in eye care products poses serious health risks, including vision-threatening infections. Although such infections are rare, they can escalate to life-threatening conditions in immunocompromised individuals.
The most common symptoms associated with fungal eye infections include:
- Eye pain
- Redness
- Blurred vision
- Sensitivity to light
- Excessive tearing
- Eye discharge
Certain populations, such as individuals with diabetes, weakened immune systems, or those using corticosteroids, may face a heightened risk of complications.
Current Status and Actions Advised
No reports of infections or adverse health outcomes have been linked to the recalled product so far. However, the FDA strongly advises consumers to:
- Stop using the affected eye drops immediately.
- Return the product to the retailer for a refund or replacement.
- Contact a healthcare provider if experiencing symptoms potentially related to fungal eye infection.
Consumers can report adverse events to the FDA’s MedWatch Adverse Event Reporting Program through its official website or by mail and fax.
Recent FDA Recalls Highlight Ongoing Safety Concerns
The recall of Systane Lubricant Eye Drops Ultra PF is the latest in a series of FDA actions addressing product safety. Earlier this week, the FDA announced recalls for several dietary supplements found to contain undeclared ingredients and a batch of blood pressure medications contaminated with potentially harmful impurities.
Consumers are encouraged to stay informed about FDA recalls by regularly checking the agency’s recall announcements and reporting any adverse effects experienced from recalled products through the MedWatch Adverse Event Reporting Program.
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