ANOTHER brand of eyedrops is recalled by FDA due to fears they contain deadly germs – as more customers fall ill with eye infections
More eye drops 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 have been detected.
The recall applies to all batches 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 that one batch of the MSM Drops 5% Solution product was not sterile, with both bacterial and fungal contamination found in the product. Dr. However, Berne’s is recalling several products ‘out of great caution’.
The products are used as lubricating eye drops, and all of the recalled drops were available nationwide through Dr. Berne.
The FDA said there were two “side effects” reported to the agency, but did not specify which they were.
This recall comes after several others were issued earlier this year after at least one person died and 68 experienced vision problems from using other eye products.
The products are used as lubricating eye drops and were distributed through the company’s website (stock image)
Dr. Berne’s will notify its distributors and customers nationwide via email and arrange for the return and refund of the products.
Customers who own the products must stop using them immediately.
The FDA states that “use of contaminated eye drops may result in a mild to severe sight-threatening infection, potentially developing into a life-threatening infection.”
Products do not pass FDA sterility testing and can become contaminated with various non-sterile substances during the manufacturing process if sterile procedures are not followed. Contaminants can be germs or even objects, such as rocks or insects.
The products of dr. Berne are not the first eye products to be recalled in the US this year. In March, EzriCare artificial tear drops were found to be contaminated with P. aeruginosa, a deadly bacteria commonly found in hospitals.
In February, Delsam Pharma Artificial Eye Ointment was recalled due to possible ‘microbial contamination’.
Other eye drops being recalled this year include Brimonidine Tartrate Ophthalmic Solution and Purely Soothing 15% MSM Drops due to potential ‘non-sterility’.
A total of 68 cases of blindness and at least one fatality were reported in the US as a result of contaminated eye drops.
The products of dr. Berne are not the first eye products to be recalled in the US this year. 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 that he has been practicing with “patients to improve their vision and overall well-being through holistic methods” for more than 25 years.
The website claims that Dr. Berne’s “complete health protocols improve vision and well-being by healing the mind-body-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 released a statement earlier this month regarding Dr. Berne, warning customers not to purchase MSM Drops 5% Solution and LightEyez MSM Eye Drops – Eye Repair and to stop using them immediately due to bacterial and fungal contamination.
“FDA recommends that consumers dispose of these products properly, as the FDA describes. Use of contaminated eye drops could result in a mild to severe, sight-threatening infection that could potentially develop into a life-threatening infection,” the FDA said on Aug. 22.
At the time, the company was not aware of any reports of side effects related to the use of its products and advised users to seek medical attention if they showed any signs or symptoms of an eye infection.
The FDA added that the products contained methylsulfonylmethane (MSM) as an active ingredient, were not approved and were illegally marketed in the US.
There are no legally marketed eye medications that contain MSM as an active ingredient.
Methylsulfonylmethane is a chemical that occurs naturally in humans. It is a powerful 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 include nausea, diarrhea, and headache.