Foreign Product Alerts: Flutulang, Kapsul Gaut (Asam Urat), and True ProLife Vegrow

Starting date:

June 4, 2013

Posting date:

June 4, 2013

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-33843

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Introduction

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.

Affected products

• Flutulang
• Kapsul Gaut (Asam Urat)
• True ProLife Vegrow

Flutulang

Product description

This product is promoted for rheumatism, backache, muscle cramps and related conditions.

Hazard identified

The Health Science Authority of Singapore advised consumers not to use this product after it was found to contain two undeclared drug ingredients, phenylbutazone and chlorpheniramine.

• Phenylbutazone was previously used to treat pain, fever, and inflammation, but is no longer authorized for sale in Canada because of its association with bone marrow suppression, which makes the body unable to fight infection.
• Chlorpheniramine is an over-the-counter antihistamine drug.

Place of origin

Packaged by Nusantara Buana Surya, Jakarta, Indonesia

Side effects

In addition to bone marrow suppression, side effects associated with phenylbutazone include reduced blood clotting ability, gastrointestinal bleeding and kidney failure.

Side effects associated with chlorpheniramine include drowsiness, dizziness, confusion and blurred vision.

Kapsul Gaut (Asam Urat)

Product description

This product is promoted for bone and muscle pain, rheumatism, and related conditions.

Hazard identified

The Health Science Authority of Singapore advised consumers not to use this product after it was found to contain the prescription drug dexamethasone.

• Dexamethasone is a steroidal prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions.  It should only be taken under the supervision of a health care practitioner. 

Place of origin

Distributed by USTAZ HAFIZ, No.63, Jitra, Kedah, Malaysia

Side effects

Side effects associated with dexamethasone include irregular heartbeat, increased blood pressure, stomach ulcer, blood disorders, skin, muscle and bone damage, and nervous system disorders.  Consult with your health care practitioner prior to stopping use, as sudden discontinuation of dexamethasone may cause symptoms of withdrawal.

True ProLife Vegrow

Product description

This product is traditionally used for strengthening the body and maintenance of general health.

Hazard identified

The Health Science Authority of Singapore advised consumers not to use this product after it was found to contain propoxyphenyl-thiohydroxyhomosildenafil, a chemical compound similar to the prescription drug sildenafil.

• Propoxyphenyl-thiohydroxyhomosildenafil is an unauthorized substance that may be similar to the prescription drug sildenafil, used to treat erectile dysfunction, and may pose similar health risks. Sildenafil should only be taken under the supervision of a health care practitioner.

Place of origin

Manufactured by Solar Victory Sdn. Bhd., of Selangor, Malaysia.

Side effects

Sildenafil should not be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as they can cause potentially life-threatening low blood pressure.  Individuals with heart problems are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat.  Other side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

What you should do

Canadians who possess any of the products listed above are advised not to use them, and should consult with a health care professional if they have concerns about their health related to the use of these products.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products 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 May 14, 2013, no adverse reactions suspected to be associated with the use of these products have been reported to Health 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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