Po Chai Pills (capsule form)

Starting date:

July 5, 2010

Posting date:

July 5, 2010

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Unauthorized products, Undeclared Substance

Audience:

General Public, Healthcare Professionals

Identification number:

RA-120001194

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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

Hong Kong Department of Health

Singapore Health Sciences Authority

Product names

Po Chai Pills (capsule form)

Manufacturer / Place of origin

Li Chung Shing Tong (Holdings) Ltd, Hong Kong

Product description

According to the product packaging, Po Chai Pills (capsule form) is indicated for the relief of the symptoms of fever, diarrhea, intoxication, over-eating and jet lag.

Please note the information in this alert refers only to the product shown below. Health Canada has authorized a product with the same name, Po Chai Pills, for sale in Canada. This authorized product, which is also manufactured by Li Chung Shing Tong (Holdings) Ltd, comes as pellets packaged in vials not as capsules packaged in blister packs. It can be identified by the Natural Product Number on the label: NPN 02247254.

Health Canada and the Hong Kong Department of Health have tested samples of Po Chai Pills in pellet form and confirmed that this product does not contain undeclared sibutramine or phenolphthalein. This alert applies to the capsule form only.

Reason for warning

The Hong Kong Department of Health (HKDH) and the Singapore Health Sciences Authority warned consumers not to buy or use Po Chai Pills (capsule form) after certain batches were found to contain undeclared sibutramine and phenolphthalein.

According to HKDH, affected batches of the capsules had been distributed to Singapore and Macau markets in addition to Hong Kong, the only three places the capsule form is marketed.

All batches of the capsule form were recalled by the manufacturer as a precaution.

Sibutramine is a prescription drug used to treat obesity. It should only be taken under the supervision of a health care practitioner.

Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer.

Possible side effects

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.

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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