News & Events

FDA in Brief: FDA warns homeopathic drug maker for serious violations in the manufacture of eye drops

For Immediate Release: Dec. 18, 2017

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  Lyndsay Meyer
  240-402-5345

"Homeopathic drug makers that fail to adhere to current good manufacturing practices are in violation of federal law, and can put the health of consumers at serious risk,” said FDA Commissioner Scott Gottlieb, M.D. “We’re working to update the FDA’s enforcement policy for homeopathic drugs products, by announcing today a new, risk-based approach that will enable us to better target products that can harm consumers or discourage them from using proven treatments for serious conditions. We’ll continue to also focus enforcement actions on poorly made drug products that have potential to cause significant safety issues."

The U.S. Food and Drug Administration today issued a warning letter to Deserving Health International in Canada for failing to implement an appropriate manufacturing process to assure the sterility of their homeopathic Symbio Muc Eye Drops 5X, which are marketed for ophthalmic use, including for “red and irritated eyes” and “allergy eyes.” By not adhering to the necessary sterility requirements, the eye drops were at risk of microbial contamination, which may cause bacterial infections in consumers. The company agreed to temporarily cease manufacturing of these products for distribution to the United States and to recall the products in September 2017.

Deserving Health also produced a product that contained penicillium notatum, which could result in penicillin contamination of their other drug products, but did not address the related risks to that marketed product or whether cross-contamination of other drug products may have occurred. Penicillin cross contamination can cause allergic reactions from mild rashes to severe and life-threatening anaphylactic reactions in some consumers.

The warning letter requests that Deserving Health International respond to the FDA identifying how the problems noted by the FDA will be corrected within 15 working days. Companies that do not correct the problems risk enforcement action such as seizure, injunction or prosecutions. Additionally, the FDA placed Deserving Health on import alert on Nov. 2, 2017 preventing their adulterated drug products from being distributed in the United States.

Health care professionals and consumers should also report any adverse events related to the use of homeopathic products to the FDA’s MedWatch Adverse Event Reporting program. To file a report, use the MedWatch Online Voluntary Reporting Form. The completed form can be submitted online or via fax to 1-800-FDA-0178.

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The FDA, an agency within the U.S. Department of Health and Human Services, protects the public health by assuring the safety, effectiveness, and security of human and veterinary drugs, vaccines and other biological products for human use, and medical devices. The agency also is responsible for the safety and security of our nation’s food supply, cosmetics, dietary supplements, products that give off electronic radiation, and for regulating tobacco products.

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