Additional dangerous products from Rapha Biotech Inc. found at  "ShopForYou" in Vancouver

Starting date:
December 5, 2014
Posting date:
December 5, 2014
Type of communication:
Advisory
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-42813

The issue:

Further to a previous communication, Health Canada testing has found three additional health products removed from sale at ShopForYou in Vancouver, B.C., with undeclared ingredients that may pose serious risks to health. The undeclared substances include sibutramine, desmethyl sibutramine, N-ethyl tadalafil and amphetamine and methamphetamine.

Who is affected:

Canadians who have purchased or used any of the following health products: RAPHA Vitamin B1, Gra-MaxX Gold (yellow label or Rapha Diet (630 mg, 270 Capsules). An additional product (Rapha Diet, 700 mg, 270 Capsules) contained undeclared caffeine, which may pose health risks to people sensitive to its effects.

What consumers should do:

  • Consult your doctor or pharmacist if you have used or are using any of the affected products.
  • Report any adverse events to Health Canada.

What Health Canada is doing:

Health Canada is following up with Rapha Biotech Inc. to determine the cause of undeclared and prohibited ingredients in its products. Health Canada will continue to monitor ShopForYou to verify that this retail location stops selling unauthorized health products to Canadians.

Should any new products or issues be identified, Health Canada will take appropriate action and inform Canadians.

Background:

Tadalafil should only be used under the supervision of a health care practitioner. Products containing tadalafil or its analogs should never be used by individuals taking any kind of nitrate drug (e.g. nitroglycerine) as it can cause potentially life-threatening low blood pressure.

Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke. In addition to heart attack and stroke, side effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Stimulants such as amphetamine and methamphetamine can increase blood pressure, heart rate, and body temperature; lead to serious cardiovascular complications (including stroke) at high doses; suppress sleep and appetite, and be addictive. Methamphetamine use can produce anxiety attacks, paranoia and hallucinations. Overdoses of methamphetamine can be fatal.

Products Affected:

  1. RAPHA Vitamin B1 (NPN: 80036493) -- undeclared ingredients: sibutramine, desmethyl sibutramine
  2. Gra-MaxX Gold (yellow label) -- undeclared ingredient: N-ethyl tadalafil
  3. Rapha Diet (700 mg, 270 Capsules) -- undeclared ingredient: caffeine
  4. Rapha Diet (630 mg, 270 Capsules) -- undeclared ingredients: amphetamine, methamphetamine

For more information:

Consumers and health professionals wanting more information about this advisory from Health Canada can contact the Public Enquiries Line at 613-957-2991, or toll free at 1-866-225-0709.

Media enquiries related to this Advisory should be directed to Health Canada Media Relations at 613-957-2983.

How to report side effects to health products to Health Canada:

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect Canada's web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax.

Stay connected with Health Canada and receive the latest advisories and product recalls using social media tools.

Media Enquiries:

Health Canada
(613) 957-2983

Public Enquiries:

(613) 957-2991
1-866 225-0709