Foreign Product Alerts: Ortiga

Starting date:

May 1, 2014

Posting date:

May 1, 2014

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Source of alert:

US FDA

Issue:

Undeclared Substance

Audience:

General Public

Identification number:

RA-39301

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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 product

• Ortiga

Ortiga

Product description

The product is promoted for a variety of health conditions.

Hazard identified

The United States Food and Drug Administration warned consumers not to use this product after it was found to contain undeclared diclofenac.

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

Place of origin

Unknown

Side effects

Side-effects associated with diclofenac include: changes in blood pressure, gastrointestinal disorders (with or without bleeding), anemia, kidney failure and reduced blood clotting ability.

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 healthcare professional 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.

As of April 15, 2014, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Report a health or safety concern

To report a side effect to a health product to Health Canada:

• 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.

Images

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