FDA Announces Nationwide Eye Drops Recall Due to Fungal Contamination

Alcon Laboratories, maker of a popular brand of eye drops, recalled part of its national supply on Dec. 23 after discovering fungal contamination in one of its products.

Alcon, the company behind the Systane brand of eye drops, said it is recalling one batch of its Systane Lubricant Eye Drops Ultra PF, in an announcement made by the Food and Drug Administration.

According to the FDA’s statement, a consumer complained to the company about “foreign material observed inside the sealed single-use vial.” After Alcon evaluated the complaint, the company determined that the substance was “fungal in nature.”

But the FDA noted, “To date, Alcon Laboratories has not received any reports of adverse events associated with this recall.”

Systane eye drops that have been withdrawn.

FDA

An Alcona spokesperson told PEOPLE that it is “conducting a voluntary recall of one (1) lot of Systane Lubricant Eye Drops Ultra PF, Single Vials On-the-Go, 25 count (Lot 10101) distributed only in the United States following the discovery of foreign material within one , unused, plastic unit-dose vials returned with a customer-reported complaint.

The investigation of this event is still ongoing; however, the presence of foreign material appears to be isolated to a single unit returned by a customer. To date, there have been no adverse events associated with this recall. However, out of an abundance of caution, Alcon initiated a voluntary recall and notified the US FDA.”

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The affected product is sold as 25 sterile, single-use vials of the solution, which consumers can use for temporary relief of eye stinging and irritation. But according to the FDA’s recall announcement, fungal contamination like those found in the recalled products could cause eye infections that can be sight-threatening and, in rare cases, life-threatening for those who are immunocompromised.

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Alcon said lot 10101 has an expiration date of 2025/09, and that the lot number and expiration dates are indicated on the product packaging. If a customer purchased the recalled product, the FDA advises that they stop using the product immediately and return it to the place of purchase for a refund or exchange.

Systane Lubricant Eye Drops Ultra PF, individual bottles On-the-Go

Eye drops that have been withdrawn.

FDA

The company also noted that it is reaching out to its distributors to advise them to dispose of any remaining stock of the recalled products.

Kroger announced that its stores in Alabama, Illinois, Indiana, Kentucky, Michigan, Missouri, North Carolina, Ohio, Tennessee and Virginia are affected by the recall. Fred Meyer, Ralphs, QFC and Publix also said their stores were affected.

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Alcona spokesman Steven Smith said the company’s investigation is still ongoing, but noted that “the presence of the foreign material appears to be isolated to the unit returned by the customer,” NBC News reported.

He added that the company’s withdrawal was done “out of an abundance of caution to make consumer safety a priority.”

In a statement to PEOPLE, an Alcona spokesperson said, “Our priority is to ensure the safety of our products while maintaining compliance with all regulatory authorities.”

Categories: Trends
Source: HIS Education

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