Archived – Red Yeast Rice, Red Yeast Rice/Policosonal Complex and Cholestrix

Starting date:

October 25, 2007

Posting date:

October 25, 2007

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Unauthorized products, Product Safety

Audience:

General Public

Identification number:

RA-12000256

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

U.S. Food and Drug Administration (FDA)

Product name

Red Yeast Rice, Red Yeast Rice/Policosonal Complex and Cholestrix

Manufacturer / Place of origin

Red Yeast Rice, Red Yeast Rice/Policosonal Complex and Cholestrix are sold by Swanson Healthcare Products, Inc. (Fargo, ND, U.S.) and manufactured by Nature's Value Inc. and Kabco Inc.

Cholestrix is sold by Sunburst Biorganics (Baldwin, NY, U.S.).

Product description

Red Yeast Rice, Red Yeast Rice/Policosonal Complex and Cholestrix are promoted as dietary supplements for the treatment of high cholesterol.

Reason for warning

The U.S. FDA warned consumers not to purchase or use these products as they contain lovastatin, a prescription medication for the treatment of high cholesterol that should be taken only under the guidance of a health professional.

Possible side effects

Lovastatin has been associated with serious adverse reactions such as liver, kidney and muscle problems. It should not be used by individuals with liver or kidney disease or by at-risk populations such as the elderly and pregnant/nursing women. Lovastatin should not be used in combination with other medications such as cholesterol-lowering agents or antibiotics (e.g., erythromycin or clarithromycin) as this may increase the risk of drug interaction leading to serious side effects.

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