Foreign Product Alerts: Zi Xiu Tang Pollen capsule and Zi Xiu Tang Beauty Face and Figure capsule

Starting date:
July 16, 2014
Posting date:
July 16, 2014
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Source of alert:

Australian Therapeutic Goods Administration

Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-40543

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

  • Zi Xiu Tang Pollen capsule
  • Zi Xiu Tang Beauty Face and Figure capsule

Zi Xiu Tang Pollen capsule and Zi Xiu Tang Beauty Face and Figure capsule

Product description

These products are promoted for weight loss.

Hazard identified

The Australian Therapeutic Goods Administration (TGA) warned consumers not to use these products after they were found to contain undeclared sibutramine, phenolphthalein, diclofenac, and ibuprofen. The product, Zi Xiu Tang Beauty Face and Figure capsule, was also found to contain undeclared glibenclamide, and indomethacin.

  • 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.
  • Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer.
  • Diclofenac, ibuprofen and indomethacin are drugs in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and are used to treat pain, fever and inflammation. Oral diclofenac and indomethacin are prescription drugs and should only be taken under the supervision of a healthcare professional.
  • Glibenclamide (also known as glyburide) is a prescription drug used to treat diabetes.  It should only be taken under the supervision of a healthcare professional.

Place of origin

Unknown

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.

Additional side effects associated with phenolphthalein include decreased blood pressure, skin rash and gastrointestinal bleeding.

Side effects associated with diclofenac, ibuprofen and indomethacin include changes in blood pressure, gastrointestinal disorders (with or without bleeding), anemia, kidney failure and reduced blood clotting ability.

Side effects associated with glibenclamide include severe low blood sugar which may cause sweating, paleness, chills, headache, dizziness and confusion.

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 products 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 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 15, 2014, 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

To report a side effect to a health product to Health Canada:

  • 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

Images

Select thumbnail to enlarge - opens in a new window