The U.S. Food and Drug Administration (FDA) has issued a recall of eye drop products manufactured by Dr. Berne’s Whole Health Products due to worries about contamination.
The voluntary recall is applicable to “all lots” of Dr. Berne’s MSM DROPS 5%, 15% Solution, Dr. Berne’s Organic Castor Oil Eye Drops, and Dr. Berne’s MSM MIST 15% Solution, according to an Aug. 26 FDA recall notice.
An analysis by the agency had found a lot of MSM DROPS 5% Solution failed “sterility with both bacterial and fungal contamination found in the product.”
The recalled products are used as lubricating eye drops and were distributed via Dr. Berne’s online store.
“Using contaminated eye drops could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection. To date, Dr. Berne’s has received 2 reports of adverse events related to this recall,” the notice said.
The company is notifying all distributors and customers by email and arranging for the return of the recalled products. Those who have bought the products have been asked to stop using them and return the items to Sun Star Organics, 988 Main Street, Orange, CA 92867.
The recall notice includes images of the products being withdrawn.
The recall comes a few days after the FDA issued a warning asking consumers not to buy and to “immediately stop” using two eye drop products—Dr. Berne’s MSM Drops 5% Solution and LightEyez MSM Eye Drops.
The products contain methylsulfonylmethane (MSM) as an active ingredient. The items are “unapproved drugs and illegally marketed” in the United States, the agency said. “There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient,”
Testing of the products revealed that they were “contaminated with microbes and were not sterile,” it stated.
Dr. Berne’s eye drops recall is the latest in a series of similar recalls done by other manufacturers in the industry.
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