Foreign Product Alerts: Ginseng Baji Gu Ci Wan, Tu Chong Ginseng Wan Le Seang and X-Tract Nature

Starting date:

November 8, 2013

Posting date:

November 8, 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-36359

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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

• Ginseng Baji Gu Ci Wan Le Seang
• Tu Chong Ginseng Wan Le Seang
• X-Tract Nature 

Ginseng Baji Gu Ci Wan and Tu Chong Ginseng Wan Le Seang

Product description

These products are promoted as Traditional Chinese Medicine used for pain relief.

Hazard identified

The Singapore Health Sciences Authority urged consumers not to use these products as they were found to contain undeclared dexamethasone and chlorpheniramine.

• Dexamethasone is a prescription drug used to treat inflammatory conditions such as arthritis and allergic reactions. It should only be taken under the supervision of a healthcare professional.
• Chlorpheniramine is a non-prescription antihistamine drug.

Place of origin

Ginseng Ginseng Baji Gu Ci Wan is manufactured by Yuzun Pharmaceuticals.

The manufacturer for Tu Chong Ginseng Wan Le Seang is unknown.

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. Consumers should consult with their healthcare provider prior to stopping their use, as sudden discontinuation of dexamethasone may cause symptoms of withdrawal.

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

X-Tract Nature

Product description

According to the package, this product is promoted to improve blood circulation, metabolism and to protect the liver, as well as prevention of stroke, diabetes, asthma, bleeding, inflammation and aging.

Hazard identified

The Singapore Health Sciences Authority warned consumers not to use this product as it was found to contain undeclared prednisone, phenylbutazone, chlorpheniramine and paracetamol.

• Prednisone 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 healthcare professional.
• 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 a non-prescription antihistamine drug.
• Acetaminophen (paracetamol) is an ingredient used in both non-prescription and prescription drugs to treat fever and pain.

Place of origin

X-Tract Nature is formulated by Dr. Muhammad. T, MPH., SpKL

Side effects

Side effects associated with prednisone include irregular heartbeat, increased blood pressure, stomach ulcer, blood disorders, skin, muscle and bone damage, and nervous system disorders.  Consumers should consult with their healthcare provider prior to stopping their use, as sudden discontinuation of prednisone may cause symptoms of withdrawal.

Phenylbutazone is associated with bone marrow suppression, which makes the body unable to fight infection. Additional 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.

Long-term use of high doses of acetaminophen (paracetamol) may cause serious liver damage.

What you should do

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.

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

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 October 25 , 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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