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Unauthorized Health Products Sold by Marigold Natural Pharmacy Ltd. May Pose Health Risks

Starting date:
July 23, 2010
Posting date:
July 23, 2010
Type of communication:
Advisory
Subcategory:
Drugs, Natural health products
Source of recall:
Health Canada
Issue:
Product Safety, Unauthorized products
Audience:
General Public
Identification number:
RA-110003641

The issue

Unauthorized health products manufactured and sold by Marigold Natural Pharmacy Ltd. may pose a risk to health and safety of Canadians. These products were made available to Canadians via the company's pharmacy in Courtenay, British Columbia and via the Marigold Natural Pharmacy Ltd. website. Marigold Natural Pharmacy Ltd. is not authorized to manufacture, package, label or import any drugs or natural health products in Canada.

A number of the unauthorized products (listed below) pose specific risks to the health and safety of Canadians: one unauthorized health product indicates that it contains Kava Kava. Kava Kava products contain kava lactones, which have been associated with severe liver damage. In addition, two unauthorized health products indicate that they contain ingredients that legally require that they be sold with a prescription because they are used to treat serious diseases or may have side effects that require monitoring by a health care practitioner.

Who is affected

Consumers who have purchased products from Marigold Natural Pharmacy in Courtenay, B.C. or via their website.

What consumers should do

  • Consult your healthcare practitioner if you have used any of these products and are concerned about your health.
  • Read the labelling of the products you buy to verify that they have been assessed by Health Canada for safety, effectiveness and quality. Health products that have been authorized for sale by Health Canada will have a single eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label.
  • Report any adverse reaction potentially related to these products to Health Canada (see below).

What Health Canada is doing

Health Canada has taken steps to mitigate the risk posed by these products and will continue to monitor Marigold Natural Pharmacy Ltd. Should Health Canada become aware that the company is continuing to sell unauthorized health products that may pose a risk to the health and safety of Canadians, Health Canada will take immediate and appropriate action.

Background

As Marigold Natural Pharmacy Ltd. does not hold a license for manufacturing, packaging and/or labelling drugs or natural health products, there is no assurance that their products were manufactured in accordance with Good Manufacturing Practices, which are standards and practices for quality assurance, product testing, manufacturing, storage, and distribution. These products have also not been assessed by Health Canada for safety, effectiveness and quality and therefore may not contain appropriate dosage instructions and cautionary statements that may lead to unsafe use of these products by Canadians.

Marigold Natural Pharmacy Ltd. was informed of Health Canada's regulatory requirements regarding the manufacture and sale of drugs in Canada. However, the company did not take the necessary steps to come into compliance with the Food and Drugs Act, the Food and Drug Regulations and the Natural Health Products Regulations and products were seized.

Products affected

  1. According to the label, Kava Kava contains kava lactones, which have been associated with severe liver damage and is on the Restricted Substances list in the Natural Health Products Compliance Guide, according to the label.
  2. According to the label, Chlorhexidine Mouthwash 0.12% contains chlorhexidine, a prescription medication.
  3. According to the label, Bueno Bone Therapy contains higher than the recommended non-prescription daily dose of vitamin D (1000 IU).

View list of all unauthorized health products

For more information

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products

To report a suspected adverse reaction to these or other health products, please contact the Canada Vigilance Program of Health Canada toll-free at 1-866-234-2345, or complete a Canada Vigilance Reporting Form and send it to us using one of these methods:

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