The US Food and Drug Administration has announced a recall of several eye products due to potential bacterial and fungal contamination. Dr. Berne’s Whole Health Products is voluntarily recalling the following items: MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops, and MSM MIST Drops 5% Solution. Although only one lot of the 5% solution failed a sterility test, Dr. Berne’s is taking precautionary measures by recalling multiple products. The contaminated eye drops were sold nationwide through Dr. Berne’s online store. The FDA has reported two adverse events related to the use of these products.
This latest recall adds to a string of similar incidents this year, including cases where individuals suffered blindness and even death as a result of using contaminated eye products. Dr. Berne’s has notified distributors and customers via email and is arranging for product returns and refunds. Customers are urged to discontinue use of the recalled products immediately.
The FDA warns that using contaminated eye drops can lead to vision-threatening infections, and potentially, life-threatening infections. Contamination can occur during the manufacturing process if proper sterile procedures are not followed. Foreign objects and germs are among the potential contaminants.
Dr. Berne’s products are not the only ones that have been recalled in the US this year. Other recalls have involved artificial tear drops, eye ointments, and other eye drops due to microbial contamination and non-sterility. In total, there have been 68 reported cases of blindness and at least one fatality related to contaminated eye drops.
Dr. Berne’s Whole Health Products was founded by Dr. Sam Berne, a private practice physician in New Mexico who has more than 25 years of experience. The company’s website states that Dr. Berne uses holistic methods to improve vision and overall wellness. However, the FDA has issued a warning about Dr. Berne’s products, citing bacterial and fungal contamination.
It is important for customers to be aware of the potential risks associated with these products and to seek medical care if they experience any signs or symptoms of an eye infection. The FDA also notes that the active ingredient, methylsulfonylmethane (MSM), in Dr. Berne’s products is unapproved and illegally marketed in the US. There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient.
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