Some Systane products are associated with mold contamination

Some Systane products are associated with mold contamination

play

Something you purchased has just been recalled. What does that mean?

What happens if something you buy is recalled? Is it voluntary or mandatory? And what does it mean for you?

Certain eye drops under the Systane brand were voluntarily recalled due to concerns about fungal contamination, which could cause eye infections and threaten users’ vision, according to a recall notice issued this week by the Food and Drug Administration.

Alcon Laboratories has voluntarily recalled a single lot of Systane Lubricant Eye Drops Ultra PF after receiving a consumer complaint of foreign material in a sealed, single-use bottle containing the eye drop solution, according to the recall notice.

The company determined the material was “mold-like in nature,” the FDA notice said.

There have been no reports of users experiencing side effects from the contaminated vials.

How do I know if my eye drops have been recalled?

According to the FDA, the following product has been recalled:

  • Systane Lubricant Eye Drops Ultra PF, single vials for on the go, 25 pieces: Lot 10101, expires in September 2025.

The eye drops are used to temporarily relieve “burning sensation and irritation in individuals experiencing symptoms of dry eye.”

They are packaged in a green and pink cardboard box with the brand names Systane” and “ULTRA PF” printed on them, the FDA said. The solution itself comes in 25 plastic bottles in the box.

The lot number of the product can be found on the bottom of the carton and on the individual vials.

Alcon Laboratories will notify retailers and people who purchased the product via letters, emails or phone calls.

Where was the solution distributed?

The solution was distributed nationally to multiple stores and online retailers.

The recalled products were sold at Publixthe chain said in a Dec. 20 recall.

What can happen if the eye drops are used?

According to the recall, the recalled eye drops may cause an eye infection.

An infection caused by the contaminated product can threaten a person’s vision and in rare cases can be life-threatening for users with weakened immune systems.

What should I do with the recalled eye drops?

Immediately stop using the recalled eye drops and return them to the store where they were purchased for a replacement or refund, the FDA notes.

Anyone who has used or purchased eye drops and experienced side effects or quality issues can report them to the FDA’s MedWatch Adverse Event Reporting. To report an experience, the FDA offers that people can do one of the following:

  • Complete and submit a report online
  • Download the form via the link or call 1-800-332-1088 to request a reporting form, complete and mail it and return it to the address on the pre-addressed form
  • Send the form by fax to 1-800-FDA-0178

Julia is a trending reporter for USA TODAY. You can contact her at LinkedInfollow her further X, formerly known as Twitter, Instagram And TikTok: @juliamariegz, or email her at [email protected]


Comments

Leave a Reply

Your email address will not be published. Required fields are marked *