Healthcare: Manufacturer recalls contaminated eye drops as FDA warns consumers about 2 brands

*The United States Food and Drug Administration warns consumers against using contaminated eye drops that can result in minor to serious vision-threatening infection, possibly progressing to a life-threatening infection

Emmanuel Akosile | ConsumerConnect

The United States (US) Food and Drug Administration (FDA) has warned consumers to not purchase, and to immediately stop using Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial contamination, fungal contamination, or both.

ConsumerConnect learnt the company has issued a voluntary recall of the affected product.

Dr. Berne’s products are distributed by Dr. Berne’s Whole Health Products; LightEyez’ products are distributed by LightEyez Limited, agency report.

FDA recommends consumers properly discard these products as it describes.

As regards the health risk of the affected product, it is noted that using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection.

However, FDA said it is not aware of any adverse event reports associated with the use of either products at this time.

Patients who have signs or symptoms of an eye infection should talk to their health care professional or otherwise seek medical care immediately, the health regulatory agency advised.

Unapproved ingredient

The Dr. Berne’s and LightEyez eye drop products also contain methylsulfonylmethane (MSM) as an active ingredient.

These products are unapproved drugs and illegally marketed in the United States.

There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient, report said.

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.

The agency’s testing indicated that 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.

FDA, therefore, encourages healthcare professionals and consumers to report adverse events or quality problems with any medicine to FDA’s MedWatch Adverse Event Reporting programme by completing and submitting the report online at MedWatch.

In March, recalled Artificial Tears Lubricant Eye Drops, manufactured by Global Pharma Healthcare and distributed by EzriCare and Delsam Pharma, were linked to three deaths, according to report.

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