More eyedrops potentially contaminated with deadly germs are being recalled by the US Food and Drug Administration.
Dr Berne’s Whole Health Products is issuing a voluntary recall of several eye products because bacteria and fungi were detected.
The recall applies to all lots of MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops and MSM MIST Drops 5% Solution.
An analysis by the FDA found one lot of the MSM Drops 5% Solution product failed sterility with both bacterial and fungal contamination found in the product. However, Dr Berne’s is recalling multiple products ‘out of an abundance of caution’.
The products are used as lubricating eye drops and all recalled eye drops were available for purchase nationwide via Dr Berne’s online store.
The FDA said there had been two ‘adverse events’ reported to the agency, but did not specify what they were.
This recall comes after several others were issued earlier this year after at least one person died and 68 developed vision problems from using other eye products.
These products are used as lubricating eye drops and were distributed through the company’s website (stock image)
Dr. Berne’s is notifying its distributors and customers nationwide via email and arranging for the return of and refund for the products.
Customers with the products should immediately stop using them.
The FDA states ‘using contaminated eye drops could result in minor to serious vision-threatening infection, which could possibly progress to a life-threatening infection’.
Products fail sterility tests by the FDA and can become contaminated with various nonsterile substances during the manufacturing process when sterile procedures are not followed. Contaminants can include germs or even objects, such as rocks or bugs.
The Dr Berne’s products are not the first eye products to be recalled this year in the US. In March, artificial tear drops manufactured by EzriCare were found to be contaminated with P. aeruginosa, a deadly bacteria usually found in hospitals.
In February, Delsam Pharma Artificial Eye Ointment was recalled because of possible ‘microbial contamination’.
Additional eye drops recalled this year include Brimonidine Tartrate Ophthalmic Solution and Purely Soothing 15% MSM Drops because of possible ‘non-sterility’.
In total, 68 cases of blindness and at least one fatality were reported due to contaminated eye drops in the US.
The Dr Berne’s products are not the first eye products to be recalled this year in the US. Earlier this year, four other products were recalled after dozens of reports of eye infections and vision problems
Dr. Berne’s Whole Health Products was founded by Dr Sam Berne, a private practice physician in New Mexico.
The company’s website states he has been practicing for more than 25 years with ‘patients to improve their vision and overall wellness through holistic methods’.
The website claims Dr Berne’s ‘whole health protocols improve vision and wellness by healing the mind-body-spirit through nutritional protocols, vision therapy, and self-care techniques’.
Recalled Dr Berne’s Whole Health Products
- MSM 5% Solution Eye Drops
- MSM 15% Solution Eye Drops
- MSM MIST Drops 5% Solution
- Castor Oil Eye Drops
An analysis by the FDA found contamination in one lot of the MSM Drops 5% Solution Eye Drops, but Dr. Berne’s is recalling multiple products ‘out of an abundance of caution’ (stock image)
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 about 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.
‘FDA recommends consumers properly discard these products as FDA describes. Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection’, the FDA said on Aug. 22.
At that time, it was not aware of any adverse event reports associated with use of the products and advised users to seek medical care if they showed signs or symptoms of an eye infection.
The FDA added the products contain methylsulfonylmethane (MSM) as an active ingredient and were unapproved and being illegally marketed in the US.
There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient.
Methylsulfonylmethane is a chemical that occurs naturally in humans. It is a potent anti-inflammatory sometimes used to treat osteoarthritis and rheumatoid arthritis. The long-term side effects of the chemical have not been studied and common side effects reported include nausea, diarrhea and headaches.