The US Food and Drug Administration is recalling more eye drops potentially contaminated with deadly germs.
Dr. Berne’s Whole Health Products is voluntarily recalling several eye products because bacteria and fungi were detected.
The recall applies to all lots of MSM Solution Eye Drops 5%, MSM Solution Eye Drops 15%, Castor Oil Eye Drops, and MSM MIST Solution Eye Drops at 5%.
An analysis by the FDA found that one batch of the 5% solution failed a sterility test, and both bacterial and fungal samples were detected. However, Dr Berne’s is recalling several products “out of an abundance of caution.”
The products are used as lubricating eye drops and all recalled drops were available for purchase nationwide through Dr. Berne’s online store. The FDA said two “adverse events” had been reported to the agency, but did not specify which ones.
This recall comes after several others were issued earlier this year after at least one person died and 68 went blind from the use of other eye products.
Several recalls have been issued for a variety of eye products from different companies throughout 2023. The products have been linked to eye infections and vision problems.
Dr Berne’s is notifying its distributors and customers nationwide by email and arranging for product returns and refunds.
Customers who have the products should stop using them immediately.
The FDA states that “use of contaminated eye drops could lead to mild to severe vision-threatening infection, possibly progressing to a life-threatening infection.”
Eye products can become contaminated with various substances during the manufacturing process when sterile procedures are not followed.
Contaminants can include germs or even objects, such as rocks or insects.
Dr. Berne’s products are not the first eye products to be recalled this year in the United States. In March, artificial tears manufactured by EzriCare were found to be contaminated with P. aeruginosa, a deadly bacterium often found in hospitals.
In February, Delsam Pharma’s artificial eye ointment was withdrawn from the market due to possible “microbial contamination”.
Other eye drops withdrawn from the market this year include brimonidine tartrate ophthalmic solution and purely soothing 15% MSM drops due to possible “non-sterility.”
In total, 68 cases of blindness and at least one death due to contaminated eye drops have been reported in the US.
Dr. Berne’s products are not the first eye products to be recalled this year in the United States. Earlier this year, four other products were withdrawn from the market after dozens of reports of eye infections and vision problems.
Dr. Berne’s Whole Health Products was founded by Dr. Sam Berne, a physician in private practice in New Mexico.
Whole Health Products Recalled from Dr. Berne’s
- MSM 5% Solution Eye Drops
- MSM 15% Eye drops in solution
- MSM MIST drops 5% solution
- castor oil eye drops
An analysis by the FDA found contamination in a batch of MSM Drops 5% solution eye drops, but Dr. Berne is recalling several products “out of an abundance of caution” (file image)
The company’s website states that it has been practicing for over 25 years with “patients to improve their vision and general well-being through holistic methods.”
The website states that “Dr. Berne’s holistic health protocols enhance vision and well-being by healing the mind, body, and spirit through nutritional protocols, vision therapy, and self-care techniques.”
At the bottom of the website is the disclaimer: ‘These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.
The FDA issued a statement earlier this month regarding Dr. Berne’s products, warning customers not to purchase and immediately stop using MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair due to bacterial and fungal contamination. .
‘The FDA recommends that consumers properly dispose of these products as outlined by the FDA. Use of contaminated eye drops could lead to a mild or severe vision-threatening infection that could possibly progress to a life-threatening infection,” the FDA said Aug. 22.
At the time, he was not aware of any reports of adverse events associated with the use of the products and advised users to seek medical attention if they exhibited signs or symptoms of an eye infection.
The FDA added that the products contain methylsulfonylmethane (MSM) as an active ingredient and were unapproved and illegally marketed in the US.
There are no legally marketed ophthalmic medications that contain MSM as an active ingredient.
Methylsulfonylmethane is a chemical that occurs naturally in humans. It is a powerful anti-inflammatory that is sometimes used to treat osteoarthritis and rheumatoid arthritis. The long-term side effects of the chemical have not been studied, and common reported side effects include nausea, diarrhea, and headaches.