Archived – Endopile Capsules

Starting date:

September 13, 2007

Posting date:

September 13, 2007

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Unauthorized products, Product Safety, Poisoning Hazard

Audience:

General Public

Identification number:

RA-12000158

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These products are not authorized for sale in Canada and have not been found in the Canadian marketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of alert

Singapore's Health Sciences Authority (HSA)

Product name

Endopile Capsules (batch number 90_16)

Manufacturer / Place of origin

Santhigiri Ayurveda and Siddha Vaidyasala, India

Product description

The product Endopile Capsules is marketed for the treatment of hemorrhoids and piles, and related symptoms. The capsules are yellow and pink in colour and are contained in plastic twist-top bottles bearing the product name.

Reason for warning

Singapore's Health Sciences Authority advised the public not to use the product Endopile Capsules (batch number 90_16) because it was found to contain potentially toxic levels of lead and mercury.

Consumption of excessive amounts of heavy metals, such as lead and mercury, pose serious health risks because they may accumulate in vital organs of the body. Children are most susceptible to the toxic effects of heavy metals.

Possible side effects

The toxic effects of lead include abdominal pain, anemia, changes in blood pressure, reproductive effects, weakness, concentration problems, weight loss, insomnia, dizziness, kidney and brain damage. The toxic effects of mercury include irritability, tremors, memory loss, insomnia, concentration problems, and can permanently damage the brain and kidneys.

What you should do

Canadians who have this product are advised not to use it, and should consult with a health care professional if they have concerns about their health related to the use of this product.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the product listed above in the Canadian marketplace.

Background

Drugs and natural health products that are authorized for sale in Canada will have either an eight-digit Drug Identification Number (DIN), a Natural Product Number (NPN) or a Homeopathic Medicine Number (DIN-HM) on the label. These numbers indicate that the products have been assessed by Health Canada for safety, effectiveness and quality.

As of the date of this posting, no adverse reactions suspected to be associated with the use of this product have been reported in Canada.

Report a health or safety concern

• Call toll-free at 1-866-234-2345.
• Visit Health 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

Images

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