Fruta Planta and Reduce Weight Fruta Planta

Starting date:

February 3, 2011

Posting date:

February 3, 2011

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-120001621

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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

• Fruta Planta
• Reduce Weight Fruta Planta

Manufacturer / Place of origin

PRock Marketing LLC, of Kissimmee, Florida, U.S.

Product description

Fruta Planta and Reduce Weight Fruta Planta are promoted as all-natural Chinese dietary supplements used for weight loss. Fruta Planta and Reduce Weight Fruta Planta is a single product marketed under two brand names, and comes packaged in 30-capsule boxes.

Reason for warning

The U.S. FDA warned consumers not to buy or use Fruta Planta and Reduce Weight Fruta Planta after FDA lab tests revealed that this product contains undeclared sibutramine.

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.

According to the U.S. FDA news release, the FDA has received multiple reports of adverse events associated with the use of Fruta Planta and Reduce Weight Fruta Planta, including several cardiac events and one death. The FDA, in their release, advised consumers to stop using the product immediately, and noted that Fruta Planta and Reduce Weight Fruta Planta is sold online at www.frutaplanta.com and other online retailers.

Possible side effects

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

Images

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