Advisory - Health products manufactured by Professional Botanicals Inc. may pose serious health risks

OTTAWA, Dec. 13, 2018 /CNW/ -

Issue
Health Canada is warning that all products manufactured by Professional Botanicals Inc. may pose serious health risks. The company is a contract manufacturer that also operates under the name Healthy Botanicals Inc.

Health Canada's assessment indicates that the company was manufacturing products under unsanitary conditions at a site that was not licensed by Health Canada at the time. During an inspection of the site (located at #16, 17075 Leslie Street, Newmarket, ON), Health Canada inspectors found that there was a lack of adequate quality control measures to ensure product quality and safety, and that no pest control measures were in place.

Health Canada has seized all of the products, prescription drug ingredients and manufacturing equipment found at the site, and suspended the 11 natural health product licences held by the company.

Products manufactured by this company may have been sold under various brand names, including Professional Botanicals Inc., either directly from the company or distributed to locations such as retail stores and weight loss clinics.

Health Canada's actions are further to the Department's follow-up regarding the sale of Vita-X Revitalizing Capsules, a natural health product manufactured by this company that was found to contain a prescription drug. As previously communicated, Health Canada has also suspended the licence for this product.

Unauthorized products have not been assessed by Health Canada for safety, quality or efficacy. It is illegal to sell unauthorized health products and conduct activities such as manufacturing, packaging and labelling of health products in Canada without the appropriate licensing and authorization from Health Canada. A site or establishment licence indicates that the company has met Health Canada's requirements for having processes and procedures in place to track and recall health products, and for manufacturing, packaging and labelling products in accordance with good manufacturing practices (a standard that helps to ensure the quality of health products sold to Canadians).

Who is affected

• Consumers who have bought or used the affected products.

Affected products

List of products for which Health Canada has suspended the licence (licenced products are indicated on the label by a Natural Product Number [NPN])

List of unauthorized products that Health Canada seized from the site (see photos below): 

What consumers should do

• Stop using these products. Consult your health care professional if you have used any of these products and have health concerns.
• Read product labels to verify that health products have been authorized for sale by Health Canada. Authorized health products have an eight-digit Drug Identification Number (DIN), Natural Product Number (NPN) or Homeopathic Drug Number (DIN-HM). You can also check whether products have a valid authorization for sale by searching Health Canada's Drug Product Database and Licensed Natural Health Product Database.
• Report any health product-related adverse reactions or complaints to Health Canada.

What Health Canada is doing

At Health Canada's request, the company has agreed to stop manufacturing and selling, and to recall, all health products manufactured at its facility.

Should additional safety concerns be identified related to this issue, Health Canada will take appropriate action and inform Canadians as necessary.

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SOURCE Health Canada