Advisory - Unauthorized "E-Fong XuDuan Concentrated Herb Tea" contains prescription drug and may pose serious health risks

OTTAWA, Nov. 3, 2017 /CNW/ -

Issue
Health Canada is advising Canadians that the unauthorized health product "E-Fong XuDuan Concentrated Herb Tea" may pose serious health risks, including an increased risk of miscarriage and birth defects. Health Canada laboratory testing found that the tea contains trace amounts of mycophenolate, a prescription drug. The product was being imported by two companies (Hunsing Enterprise Ltd. and Aidus International), which distributed the product to other retailers and distributors, including clinics that provide Traditional Chinese Medicine services.

Who is affected

• Consumers who have bought or used E-Fong XuDuan Concentrated Herb Tea

Affected products

• E-Fong XuDuan Concentrated Herb Tea

What consumers should do

• Stop using this product. Consult with your health care professional if you have used it and have health concerns.
• Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have been authorized for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
• Report adverse events to health products to Health Canada by calling toll-free at 1‑866‑234‑2345, or by reporting online, by mail or by fax.
• Report complaints about health products to Health Canada by calling toll-free at 1‑800‑267‑9675, or complete an online complaint form.

Background
Mycophenolate is a prescription drug used after kidney, heart and liver transplants to help prevent organ rejection. It works by reducing or suppressing the body's immune response. The drug is associated with serious side effects, including an increased risk of miscarriage and birth defects. It should not be used by pregnant women, or by women who may become pregnant unless they are using reliable methods of birth control. Sexually active men are recommended to use condoms if they are using the drug, and for at least 90 days after stopping use. This is because women may be exposed to the drug through semen, which could lead to birth defects. Although consuming trace amounts is unlikely to result in these side effects, it is not known what specific dose may cause these effects.

What Health Canada is doing
Health Canada seized the product from the two known importers— Hunsing Enterprise Ltd., located in Ontario, and Aidus International, located in British Columbia. Based on test results confirming the presence of mycophenolate, Health Canada requested that both importers recall the product. Health Canada will take further action as necessary to prevent the import and sale of this product in Canada.

For more information
Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

To learn more about natural health products and other self-care products, visit Canada.ca/selfcare-products.

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SOURCE Health Canada