ArimaDex and Clomed

Starting date:

December 16, 2010

Posting date:

December 16, 2010

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Undeclared Substance, Unauthorized products

Audience:

General Public

Identification number:

RA-120001369

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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

U.S. Food and Drug Administration

Product names

• ArimaDex
• Clomed

Manufacturer / Place of origin

ArimaDex is manufactured by Genetic Edge Technologies (G.E.T.) Inc. of Phoenix, Arizona, U.S.

Clomed is manufactured by KiloSports Inc. of Phoenix, Arizona, U.S.

Product description

ArimaDex and Clomed are promoted as bodybuilding supplements.

ArimaDex comes in white bottles with orange labels containing 60 orange soft gels. The packaging bears the UPC Code 718122466511.

Clomed comes in plastic black bottles with black safety caps containing 60 white or clear capsules. The packaging bears the UPC Codes 8 58515 00265 7 & 8 5851500096 7.

Reason for warning

The U.S. Food and Drug Administration informed consumers that ArimaDex and Clomed are being recalled in the U.S. because they may contain an aromatase inhibitor. ArimaDex and Clomed and are being voluntarily recalled by G.E.T. and KiloSports Inc., respectively.

Aromatase inhibitors are a class of prescription drugs used in the treatment of breast cancer and ovarian cancer in postmenopausal women, and should only be taken under the supervision of a health care practitioner.

According to company-issued news releases, both ArimaDex and Clomed were distributed throughout the U.S. and could be purchased at retail stores, or via mail order and the Internet.

Consumers can return the products to the place of purchase for a full refund, and may call the company directly with any questions:

• G.E.T.: 1-480-248-7957
• KiloSports Inc.: 1-480-545-3489

Possible side effects

Side effects associated with aromatase inhibitors include decreased rate of bone maturation and growth, decreased sperm production, infertility, aggressive behaviour, adrenal insufficiency, kidney failure, and liver dysfunction.

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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