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Contamination Alert Announced for Eye Drop Products

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Contamination Alert Announced for Eye Drop ProductsAnother contamination has been spotted in eye drop products sold and distributed in the United States.

The U.S. Food and Drug Administration released a warning last week against the continued use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops. Testing revealed bacterial contamination, fungal contamination, or both. The FDA recommends disposing these products immediately.

The latest announcement comes just months after a deadly outbreak of Pseudomonas aeruginosa was linked to eyedrops and eyecare ointment. There have been no updates in that ongoing investigation since mid May.

The FDA says it is unaware of any adverse effects associated with last week’s announcement. However, it warns that continued use of contaminated eye drops poses a serious risk of infection. Anyone who is experiencing a symptom of an eye infection is urged to seek the advice of a health care professional.

In addition, both the Dr. Berne’s and LightEyez eye drop products attached to this warning contain an active ingredient called methylsulfonylmethane (MSM). The FDA reports that “There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient.” As such, these products are unapproved drugs and are being illegally marketed in the U.S.

Here’s more from the FDA announcement:

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FDA conducted sampling and testing based on these products’ intended use in the eyes, and due to the industry’s recent manufacturing issues with eye drops. FDA’s testing showed the products were contaminated with microbes and were not sterile. Under the Federal Food, Drug and Cosmetic Act, eye drops must be sterile to be safe for use. The table below includes examples of specific microbes isolated from FDA testing.

Dr. Berne verbally agreed on August 21, 2023, to voluntary recall the Dr. Berne’s MSM Drops 5% Solution.

FDA emailed LightEyez Limited on August 21, 2023 seeking to discuss FDA’s concerns with LightEyez products distributed in the U.S. and further steps to protect consumers from using the contaminated eye drops. To date, LightEyez has not responded to FDA or taken action to protect consumers.

FDA encourages health care professionals and consumers to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting program:

  • Complete and submit the report online at Medwatch; or
  • Download and complete the form, then submit it via fax at 1-800-FDA-0178.

 

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