Archived – Zhixhue Capsules

Starting date:

January 30, 2009

Posting date:

January 30, 2009

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information

Audience:

General Public

Identification number:

RA-12000781

• Media enquiries
• Public enquiries

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

China's State Food and Drug Administration (SFDA)

Product name

There are many products containing the name "Zhixhue"; this alert applies only to the Zhixhue Capsules manufactured by the company named below.

Manufacturer / Place of origin

Vital Pharmaceutical Holdings Ltd. / Sichuan Province, China

Product description

Zhixhue Capsules are promoted for the treatment of haemorrhoids. (No image is available for this product.)

Reason for warning

The SFDA warned consumers not to buy or use Zhixhue Capsules following several reports of liver dysfunction and other adverse reactions in people who had been using the product.

The SFDA ordered the manufacturer to stop producing the capsules and initiated a nationwide recall. The exact cause of the adverse reactions is unknown.

Possible side effects

The reports of liver dysfunction included abnormal liver blood tests and hepatitis. The other reported adverse reactions were not specified.

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