Recall of Dr. Berne's and LightEyez Eye Drops
Medically reviewed by Drugs.com.
By Physician’s Briefing Staff HealthDay Reporter
WEDNESDAY, Aug. 23, 2023 -- The U.S. Food and Drug Administration on Tuesday advised people to avoid purchasing and immediately stop using Dr. Berne's MSM Drops 5 percent Solution and LightEyez MSM Eye Drops—Eye Repair because the drops may be contaminated with bacteria, fungus, or both.
Specific microbes isolated from FDA testing include Bacillus (a bacterium) and fungal Exophiala in the Dr. Berne's MSM Drops 5 percent Solution. In the LightEyez MSM Eye Drops—Eye Repair, FDA testing detected bacteria including Pseudomonas, Mycobacterium, Mycolicibacterium, and Methylorubrum.
The Dr. Berne's products are distributed by Dr. Berne's Whole Health Products. The company agreed on Monday to a voluntary recall of those particular eye drops. The LightEyez products are distributed by LightEyez Limited. LightEyez has not responded to an FDA email seeking to discuss the FDA concerns, the agency said.
So far, no one has reported adverse events from using the drops, the FDA said, but the products should be thrown out because using them could lead to minor or serious vision-threatening infections that could progress to a life-threatening infection, the agency warned. Patients who have signs or symptoms of an eye infection should talk to their health care professional or seek immediate medical care.
The two eye drops included in the warning also contain methylsulfonylmethane (MSM) as an active ingredient. According to the FDA, no legally marketed ophthalmic drugs contain MSM as an active ingredient, so these products are unapproved drugs and illegally marketed in the United States. Eye drops are required by federal law to be sterile to be safe for use. The FDA said that it had sampled and tested these products because of the eye drop industry's recent manufacturing issues with eye drops.
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Disclaimer: Statistical data in medical articles provide general trends and do not pertain to individuals. Individual factors can vary greatly. Always seek personalized medical advice for individual healthcare decisions.
© 2024 HealthDay. All rights reserved.
Posted August 2023
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