Eye Drops by Dr. Berne’s Whole Health Products Pulled Off Shelves Amid Contamination Concerns
The United States Food and Drug Administration (FDA) has issued a recall for several eye care items sold by Dr. Berne’s Whole Health Products due to fears of bacterial and fungal contamination.
The company is voluntarily pulling multiple products, including MSM 5% Solution Eye Drops, MSM 15% Solution Eye Drops, Castor Oil Eye Drops, and MSM MIST Drops 5% Solution, from the market.
The FDA’s tests indicated that a batch of MSM Drops 5% Solution was not sterile and showed signs of both bacterial and fungal contamination. As a precautionary measure, Dr. Berne’s is also recalling additional products.
These eye care items, intended for eye lubrication, were available for purchase throughout the United States via the company’s online storefront.
While there have been two undisclosed ‘adverse events’ associated with these products, the FDA has not elaborated on the nature of these incidents.
This latest recall follows a series of other similar events earlier in the year. These earlier recalls were linked to at least one fatality and 68 cases of vision impairment caused by the use of contaminated eye care products.
For those who have purchased the recalled products, Dr. Berne’s is coordinating refunds and return procedures through email notifications to both distributors and consumers across the country.
Customers are strongly advised to cease using these products immediately. The FDA warns that usage of contaminated eye drops could lead to anything from mild to severe vision-related infections, with some cases even being life-threatening.
It’s worth noting that product contamination often occurs when sterility protocols are not strictly adhered to during manufacturing, introducing elements such as harmful germs or foreign particles.
Previously this year, other eye care products like artificial tear drops produced by EzriCare and Delsam Pharma’s Artificial Eye Ointment were also pulled from the market due to microbial contamination. Other brands like Brimonidine Tartrate Ophthalmic Solution and Purely Soothing 15% MSM Drops were also recalled for sterility concerns.
Dr. Berne’s Whole Health Products was established by Dr. Sam Berne, a New Mexico-based private practice physician with over 25 years of experience. The company’s website claims to focus on a holistic approach to vision and overall well-being, incorporating nutritional protocols, vision therapy, and self-care methods.
The company’s online disclaimer states that the FDA has not evaluated these claims and that their products are not intended for diagnosing, treating, curing, or preventing any diseases.
Earlier this month, the FDA had released a warning advising consumers against the purchase and use of Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops, citing contamination issues.
According to the FDA, these eye drops included the active ingredient methylsulfonylmethane (MSM), which is not approved for ophthalmic use in the United States. MSM is a naturally occurring chemical in humans and has anti-inflammatory properties, commonly used in the treatment of conditions like osteoarthritis and rheumatoid arthritis. However, its long-term effects and common side effects such as nausea, diarrhea, and headaches have not been well-studied.
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