Pancre-Plus

Starting date:

November 9, 2011

Posting date:

November 9, 2011

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Undeclared Substance, Unauthorized products

Audience:

General Public

Identification number:

RA-120001586

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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

Product names

Pancre-Plus (counterfeit)

Manufacturer / Place of origin

Distributed in Hong Kong by Bio-Tech Chinese Medicine Laboratory Ltd. (Bio-Tech).

Product description

This counterfeit product, labelled as Pancre-Plus, is promoted as a Chinese medicine used for "enhancing blood circulation, nourishing and protecting the health of the liver and also stabilizing blood glucose level."

Reason for warning

The Hong Kong Department of Health (DH) warned consumers not to use a counterfeit product labelled as Pancre-Plus after it was found to contain undeclared glibenclamide and phenformin.

Glibenclamide (also known as glyburide) is a prescription drug used to treat diabetes. It should only be taken under the supervision of a health care practitioner. 

Phenformin was previously used to treat type 2 diabetes but is no longer authorized in Canada because of its association with a life-threatening risk of lactic acidosis, an often fatal metabolic disorder in which an abnormal amount of lactic acid accumulates in the blood.

The DH investigated the product after receiving a report of a 60 year-old man who had used it and developed hypoglycaemia (low blood sugar). According to the DH alert, the Pancre-Plus product he had been taking was a counterfeit version of a similar, licensed product that had been manufactured by a different company in Hong Kong, but that had not been produced for at least two years.

The DH instructed the manufacturer of the counterfeit product, Bio-Tech, to recall the counterfeit product from the Hong Kong market.

No product named Pancre-Plus is authorized in Canada.

Possible side effects

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

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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