Unauthorized health product sold on amazon.ca

Starting date:

November 20, 2015

Posting date:

November 20, 2015

Type of communication:

Advisory

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Physical Hazard, Unauthorized products

Audience:

General Public

Identification number:

RA-55926

• 
  Issue
• 
  Products affected
• 
  What you should do
• 
  Who is affected
• 
  Background
• 
  Report health or safety concerns
• 
  Media enquiries
• 
  Public enquiries
• 
  What Health Canada is doing

Issue

Health Canada is informing Canadians that an unauthorized health product, Natrol DHEA 25mg, was being sold on amazon.ca for hormonal management. It may pose serious risks to health.

Products affected

Natrol 25mg DHEA, 180 tablets

What you should do

• Consult your doctor if you have used this product and have health concerns.
• Read the label 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 an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label. Products that have been authorized for sale can be found by searching the Drug Product Database and the Licensed Natural Health Product Database.
• Report any adverse events to Health Canada.
• Report complaints about health products to Health Canada by calling toll-free to 1-800-267-9675, or complete an online complaint form.

Who is affected

• Consumers who have bought or used Natrol DHEA.
• DHEA should in particular be avoided by people with a history of abnormal heart rhythms, blood clotting disorders, liver disease and women who are pregnant or breast feeding.

Background

DHEA is a controlled drug that can cause higher than normal levels of female and male hormones in the body and could increase the risk of prostate, breast, ovarian, and other hormone-sensitive cancers. Potential side effects include serious cardiovascular disease and changes in fertility and sperm production. DHEA should be avoided by individuals with a history of abnormal heart rhythms, blood clotting disorders, liver disease and those who are pregnant or breast-feeding.

Report health or safety concerns

• Call toll-free at 1-866-234-2345
• Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Media enquiries

Health Canada

613-957-2983

Public enquiries

613-957-2991

1-866-225-0709

What Health Canada is doing

Amazon.ca has removed the advertisement from their site after being contacted by Health Canada The department has also issued a compliance letter to the online seller "Maple Leaf Naturals."

Health Canada continues to work with amazon.ca to identify the promotion and sale of unauthorised health products and will take action to remove products from sale and inform Canadians as appropriate.