Eye drop recall grows after FDA warning, reports of ‘adverse events’

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(WJW) — A nationwide recall of tainted eye drops is growing after bacterial and fungal contamination were found in sample tests, according to the Food and Drug Administration (FDA).

Dr. Berne’s Whole Health Products is now voluntarily recalling all lots of the company’s MSM Drops 5% Solution, 15% Solution, Organic Castor Oil Eye Drops and MSM Mist 15% Solution.

The FDA says Dr. Berne’s has received reports of “two adverse events” related to the recall and warns that the contamination could cause the loss of vision or a life-threatening infection.

According to the Dr. Berne’s website, Dr. Sam Berne has helped patients in New Mexico for over 25 years “to improve their vision and overall wellness through holistic methods.”

At the bottom of the website is the disclaimer: “These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure or prevent any disease.”

(Credit: FDA)
(Credit: FDA)
(Credit: FDA)
(Credit: FDA)
(Credit: FDA)

On Aug. 22, the FDA announced in a statement that tests of Dr. Berne’s MSM Drops 5% Solution detected bacterial and fungal contamination.

To sell eye drops in the U.S., the product must be sterile to be safe for use, the Food, Drug and Cosmetic Act states. The drops were being illegally marketed and would never have been deemed safe, according to the FDA, because they contain methylsulfonylmethane (MSM) as an active ingredient.

“There are no legally marketed ophthalmic drugs that contain MSM as an active ingredient,” the release stated.

Consumers, distributors or retailers who bought the recalled Dr. Berne’s products should stop using them and return the drops to Sun Star Organics, 988 Main Street, Orange, CA 92867.

The FDA is asking healthcare professionals and consumers to report any health or quality problems related to a medicine via the FDA’s MedWatch Adverse Event Reporting program.