Dr. Berne’s expands eye drop recall over contamination concerns
By Katherine Dillinger, CNN
(CNN) — Dr. Berne’s Whole Health Products is expanding a recall of eye drop products after an analysis by the US Food and Drug Administration found that one lot was contaminated with bacteria and fungus.
The recall now involves Dr. Berne’s MSM Drops 5% and 15% solutions, MSM Mist 15% Solution and Organic Castor Oil Eye Drops that were distributed through the company’s website. Methylsulfonylmethane or MSM is a naturally occurring organosulfur compound popular in complementary and alternative medicine.
Consumers should stop using these products, as use “could result in minor to serious vision-threatening infection which could possibly progress to a life-threatening infection,” according to an announcement on the FDA’s website. There have been two reports of adverse events related to the recall.
The FDA announced last week that Dr. Berne’s was recalling its MSM Drops 5% Solution after sampling and testing of one lot revealed contamination. The recall is now being expanded “out of an abundance of caution.”
“We have sample tested all our products with a 3rd party lab and will be publishing the findings on our site soon,” Dr. Berne’s says on its website. “All have come back with no microbial growth. If you would like a replacement bottle (tested negative batch and with the manufacturer label), please contact the manufacturer. Alternatively, you can request a refund at hello@drsamberne.com.”
The FDA says consumers who have experienced any problems should reach out to their health care provider. Adverse reactions or quality problems can also be reported through the agency’s MedWatch program.
The-CNN-Wire
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