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OxyELITE Pro capsules (often promoted as Oxy Elite Pro capsules) and Pure Fat Three Days Reduce Weight capsules

Starting date:
October 17, 2010
Posting date:
October 17, 2010
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-120001530

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

Australian Therapeutic Goods Administration (TGA)

Product names

  • OxyELITE Pro capsules (often promoted as Oxy Elite Pro capsules)
  • Pure Fat Three Days Reduce Weight capsules

Manufacturer / Place of origin

Unknown.

Product description

OxyELITE Pro capsules is promoted as having "super thermogenic" (weight loss) properties.

Pure Fat Three Days Reduce Weight capsules is promoted asa 100% herbal product used for weight loss.

Reason for warning

The Australian TGA warned consumers not to use these products after OxyELITE Pro capsules was found to contain undeclared yohimbine while Pure Fat Three Days Reduce Weight capsuleswas found to contain undeclared sibutramine.

Yohimbine is a prescription drug used to treat abnormal blood pressure. It should only be taken under the supervision of a health care practitioner.

Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke.

Possible side effects

Side-effects associated with yohimbine include abnormal blood pressure and heartbeat, anxiety, tremors, headache, nausea and sleep disorders.

In addition to heart attack and stroke, side-effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

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

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.

Report health or safety concerns

• 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


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