Health Canada Warns Consumers That The Unauthorized Natural Health Product Kwan Loong Medicated Oil May Cause Adverse Health Effects

Advisory
2008-177
November 27, 2008 (revised December 3, 2008)
For immediate release

OTTAWA - Health Canada is advising consumers not to use the unauthorized product, Kwan Loong Medicated Oil, as it contains chloroform. Sale of chloroform for human use is prohibited under the Food and Drug Regulations. The product Kwan Loong Medicated Oil labelled as containing chloroform is not the same product as the market authorized Kwan Loong Oil with the 8 digit DIN/NPN 00791903 on its product label.

Skin contact should be avoided as chloroform can cause irritation, burns, and can also penetrate the skin and produce toxic side effects similar to those produced by inhalation (i.e. anesthesia). Consumers who use this product with the application of external heat, such as an electric heating pad, are at an increased risk of excessive skin irritation or burn and toxic side effects. This product also contains methyl salicylate and should not be used by consumers who are allergic to salicylates or by those taking anticoagulant medications.

Kwan Loong Medicated Oil is manufactured by How Par Healthcare Ltd., Singapore, and was imported by Golden Mountain Ginseng Products Ltd. and distributed by Splendid Trading Ltd. Burnaby, B.C.

The product was sold in a Montreal retail store between 2006 and 2007. The retailer has voluntarily removed remaining stock from their shelves. Health Canada is taking steps to confirm that the product has been removed from the Canadian market.

Consumers are advised to immediately discontinue use of Kwan Loong Medicated Oil and consult their health care professional if they have related health concerns. The product should be kept out of reach of children and returned to the point of purchase or the manufacturer for safe disposal.

Kwan Loong Medicated Oil is not authorized for sale in Canada. The market authorized Kwan Loong Oil will contain the 8 digit DIN/NPN 00791903 on its product label and does not list chloroform as an ingredient. 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.

Kwan Loong Medicated Oil package insert

Health Canada also advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find this product for sale in Canada.

Consumers requiring more information about this advisory can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

• Report online at the MedEffect™ Canada Web site
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and either:
  • Fax toll-free to 1-866-678-6789
  • Mail to:
    
    Canada Vigilance Program
    Health Canada
    AL 0701C
    Ottawa, ON K1A 0K9

To have postage pre-paid, download the postage paid label from the MedEffect™ Canada Web site. The Canada Vigilance Reporting Form and the adverse reaction reporting guidelines may also be obtained via this Web site.

- 30 -

---

Media Inquiries:
Health Canada
(613) 957-2983

Public Inquiries:
(613) 957-2991
1-866 225-0709