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Foreign Product Alert: Compound Danshen Dripping Pills

Starting date:
October 9, 2013
Posting date:
October 9, 2013
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Unauthorized products, Suspected quality concern
Audience:
General Public
Identification number:
RA-36157

Introduction

This product is not authorized for sale in Canada and has not been found in the Canadian marketplace, but it is possible it may have been brought into the country by travellers or purchased over the Internet.

Affected products

Unauthorized Compound Danshen Dripping Pills. This alert does not apply to licenced products containing danshen. 

Compound Danshen Dripping Pills 

Product description

This unauthorized product is promoted for the treatment of coronary heart disease and angina. These claims are not acceptable for Natural Health Products.

Hazard identified

Health Canada is warning consumers not to use this unauthorized product after it was associated with a Canadian case of methemoglobinemia, a rare but serious condition which may result in coma or death.  

Place of origin

According to the product packaging, the product was manufactured in China by Tianjin Tasly Pharmaceutical Co., Ltd. 

Side effects

Symptoms of methemoglobinemia include blueness of the skin and lips, tiredness, headache, fainting, shortness of breath, palpitations, chest pain and seizures. Methemoglobinemia may result in coma or death. 

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 this product are advised not to use it, and should consult with a health care practitioner if they have concerns about their health related to the use of this product.

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. Some products may also still have an Exemption Number (EN). Health Canada has allowed a transition period for industry to move natural health products through the market that were labelled with temporary EN numbers.

As of September 27, 2013, one adverse reaction suspected to be associated with the use of this product has 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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