The U.S. Food and Drug Administration announced Saturday that a New Mexico-based company is voluntarily recalling its eyedrops after bacteria and fungus were found in one lot of Dr. Berne's MSM Drops 5% Solution.
"FDA analysis has found one lot (lot 6786) of Dr. Berne's MSM DROPS 5% Solution to fail sterility with both bacterial and fungal contamination found in the product," the agency said in the announcement. "Out of an abundance of caution, Dr. Berne's is recalling all other lots of the 5% and 15% strengths of MSM Solution and all lots of Dr. Berne's Organic Castor Oil eyedrops and Dr. Berne's MSM MIST 15% Solution."
The Daily Mail reported in May that four people died and 13 experienced vision loss after using another company's eyedrops that were contaminated with bacteria from EzriCare and Delsam Pharma-branded drops, which were made at an Indian factory with several infection control failings.
According to the FDA, using contaminated eyedrops could pose a risk of a minor or severe vision infection that could turn life-threatening.
The FDA said the company had received two reports of "adverse reactions" related to the recall.
Owner Dr. Sam Berne has been in private practice in New Mexico for more than 25 years and works with patients to improve vision and overall wellness through holistic means, according to his website.
The eyedrops products were removed from his website as of Wednesday and exchanged for a "letter to the community" by Berne.
"The FDA has done a random investigation on one of my products, the 5% MSM Lot #6786. They found microbial growth in the sample they tested. Both the FDA and I recommend a recall on all MSM and Castor Oil products. Please discontinue using all unexpired products that you may have on hand," Berne's letter on the site said.
"We have sample-tested all our products with a 3rd party lab and will be publishing the findings on our site soon. All have come back with no microbial growth."
According to the FDA, the recalled products are used as lubricating eyedrops and are packaged in 30ml/1.014 oz. plastic bottles and are sold on the company's website.
The agency advises anyone experiencing an adverse reaction to the products to report it to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail, or by fax.
The FDA announcement said users should also consult a physician or healthcare provider.
Consumers with questions about the recall can contact Dr. Berne's Whole Health Products at (877) 239-3777 or by e-mail at hello@srsamberne.com.
Consumers/distributors/retailers that have the recalled product should stop using it and return it to Sun Star Organics, 988 Main Street, Orange, California, 92867.
Charles Kim ✉
Charles Kim, a Newsmax general assignment writer, is an award-winning journalist with more than 30 years in reporting on news and politics.
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