Huo Luo Jing Dan

Starting date:

July 29, 2010

Posting date:

July 29, 2010

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Undeclared Substance

Audience:

General Public

Identification number:

RA-120001243

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These products are not authorized for sale in Canada and have not been found in the Canadianmarketplace, but it is possible they may have been brought into the country by travellers or purchased over the Internet.

Source of Alert

Singapore Health Sciences Authority (HSA)

Product Names

Huo Luo Jing Dan

Manufacturer / Place of Origin

The product insert indicates that the manufacturer is "China Tian Jin Ren Ji." However, the HSA investigation revealed that this manufacturer is fraudulent and does not exist.

Product Description

Huo Luo Jing Dan is promoted for the relief of arthritis symptoms. According to the packaging, the product is used "to improve blood circulation, to relieve pain and inflammation, and to relieve rheumatism, arthritis, limbs numbness, body ache, immobility."

The product comes packaged in a dark plastic bottle with a gold-coloured label and contains red capsules.

Reason for Warning

The Singapore Health Sciences Authority warned consumers not to buy or consume Huo Luo Jing Dan after it was found to contain undeclared indomethacin, dexamethasone and prednisolone.

The HSA tested the product after they received a report involving a hospitalized female in her 50s. The patient's face was noted to be round, red and full, which is a sign associated with long-term use of steroids. The woman had been reportedly taking the product for 12 years.

Indomethacin is a prescription drug in the family known as non-steroidal anti-inflammatory drugs (NSAIDs) and is used to treat pain, fever and inflammation. Indomethacin should only be used under the supervision of a health care practitioner.

Dexamethasone and prednisolone are steroidal prescription drugs used to treat inflammatory conditions such as arthritis and allergic reactions. They should only be used under the supervision of a health care practitioner.

Possible Side-Effects

Side-effects associated with indomethacin include gastrointestinal disorders (with or without bleeding), anemia, kidney failure and reduced blood clotting ability.

Side-effects associated with dexamethasone and prednisolone 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 or prednisolone may cause symptoms of withdrawal.

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

Images

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