RGC-RMC Rheumax Capsule (batch number REM1-SI93016N)

Foreign Product Alert
2008-14
January 28, 2008
For immediate release

Health Canada is advising consumers not to use the products specified below due to concerns about possible side-effects. More info

Date of alert: January 28, 2008
Source of Alert: Health Sciences Authority of Singapore
Product Name: RGC-RMC Rheumax Capsule (batch number REM1-SI93016N)

Manufacturer / Place of Origin
Manufactured by J & J DeChane Laboratories Private Limited and distributed by Royal Medical Consultancy / India

Product Description
RGC-RMC Rheumax Capsule is a natural health product of unknown indication. It is packaged in bottles with 30 capsules per bottle.

Reason for Warning
The Health Sciences Authority of Singapore recalled this batch of RGC-RMC Rheumax Capsule as it was found to contain progesterone, a steroid hormone used in treatments for recurrent pregnancy loss, contraception, and hormone replacement therapy. Progesterone-containing products should be taken only if prescribed and monitored by a health professional.

Possible Side Effects
Possible side-effects of progesterone include breast pain and swelling, hair loss, rash, headache, as well as mood swings, irritability, fatigue and depression. Persons with blood clot disorders, liver disorders, breast cancer or coronary artery disease, as well as pregnant women are particularly at risk of serious adverse health effects associated with the use of progesterone.

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Media Inquiries:
Health Canada
(613) 957-2983

For more details on these Foreign Product Alerts, please visit the Health Canada Web site.

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This product is not authorized for sale in Canada and has not been found in the Canadian marketplace. However, it is possible this product could be purchased by Canadians travelling abroad or has been brought into Canada through personal importation by travellers or purchased over the Internet.

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.

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.

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find any of the products listed above in the Canadian marketplace.

For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.

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.