Advisory – Removal of Potentially Dangerous Products from Retail Locations in B.C. and Saskatchewan
OTTAWA, May 23, 2012 /CNW/ -
The issue:
Unauthorized health products, “X-Rock”, “Kaboom” and “One For Her” have
been removed from sale from various retail outlets in British Columbia
and Saskatchewan. Health Canada’s testing of these products identified
undeclared prescription drugs sildenafil, and tadalafil and an
undeclared substance, hydroxythiohomosildenafil, which is similar to
sildenafil. These products may pose serious cardiovascular risks to the
health of Canadians.
The products were distributed by “It Erotics” to: an additional Happy
Paradise Adult Store in Burnaby, BC; Ultimate Amore in Burnaby, B.C.;
Source Adult in Coquitlam, B.C.; O’Behave Home Parties Ltd. in Surrey,
BC and Source Adult in Saskatoon, Saskatchewan. It is important to note
that these products may have been sold in additional retail locations.
Who is affected:
Canadians who have purchased “X-Rock”, “Kaboom” and/or “One For Her”
particularly individuals with heart problems, those at risk of stroke
or those taking any nitrate drug (e.g. nitroglycerine).
_____________________________________________________________________
|What consumers should do: |
| |
| |
| -- Speak to your healthcare practitioner with any questions or |
| concerns regarding these products. |
| -- Contact It Erotics at 604-540-4238 concerning the recall of |
| this product. |
| -- Report any adverse reaction potentially related to these |
| products to Health Canada (see below). |
| -- Read the label of the products you buy to verify that they |
| have been assessed by Health Canada for safety, effectiveness|
| and quality. Health products that have been authorized for |
| sale by Health Canada will have an eight-digit Drug |
| Identification Number (DIN), a Homeopathic Medicine Number |
| (DIN-HM) or a Natural Product Number (NPN) on the label. Some|
| natural health products (NHPs) may have an Exemption Number |
| (EN), which indicates that the product is legally available |
| for sale while Health Canada is reviewing its application for|
|________licensing.___________________________________________________|
What Health Canada is doing:
Health Canada is monitoring the voluntary recall by “It Erotics” and has
requested that they stop selling unauthorized health products.
Background:
Sildenafil and tadalafil are prescription medications that should only
be used under the supervision of a health care practitioner. Products
containing sildenafil or tadalafil 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. Individuals with heart
problems including high blood pressure, a history of heart attack,
stroke, abnormal heart beat or chest pain are at higher risk of
cardio-vascular side effects if they engage in sexual activity,
including if they use sildenafil or tadalafil to help them achieve an
erection. Other possible side-effects of using sildenafil include
headache, facial flushing, indigestion, dizziness, abnormal vision and
hearing loss.
Hydroxythiohomosildenafil is an unauthorized substance similar to
sildenafil.
As of today, Health Canada has not received any adverse reactions
reports associated with the use of these products.
_______________________________________________________________________________________________
|Products affected: |
|http://files.newswire.ca/1043/health.pdf|
|_______________________________________________________________________________________________|
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 report suspected adverse reaction to these or other health products,
please contact Health Canada’s Canada Vigilance Program toll-free at
1-866-234-2345, or complete a Canada Vigilance Reporting Form and send to us using one of these methods:
-- Fax: 1-866-678-6789
-- Internet:
www.healthcanada.gc.ca/medeffect
-- Mail: Canada Vigilance Program
Marketed Health Products Directorate
Ottawa, ON, Address Locator 0701E
K1A 0K9
Related Health Canada Web content:
-- Advisory (January 23, 2012):
"Unauthorized Products Removed from Sale at Additional Stores in
Burnaby, B.C.
-- Advisory (July 6, 2011):
14 Additional Unauthorized Health Products Tested: May Pose Serious
Health Risks
-- Advisory (July 4, 2011):
"Man Up Now" Removed From Sale at Delta and Surrey Stores: May Pose
Serious Health Risks to Canadians
-- Advisory (June 14, 2011):
Unauthorized Health Products Removed From Sale at Burnaby and Richmond
Stores: May Pose Serious Health Risks to Canadians
-- Advisory (July 13, 2010):
Unapproved Health Product "UP Ultimate Performance For Men" May Pose
Serious Health Risks
-- Advisory (March 8, 2010):
Unapproved Health Product, "POWER-MAX" May Pose Serious Health Risks
-- Advisory (January 8, 2010) -
Canadians Advised Not to use "Stiff Nights" or Any Unauthorized Product
Promoted for Erectile Dysfunction
Stay connected with Health Canada and receive the latest advisories and
product recalls using these social media tools: http://www.hc-sc.gc.ca/home-accueil/sm-ms/index-eng.php
Également disponible en français
SOURCE Health Canada
PDF available at: http://stream1.newswire.ca/media/2012/05/23/20120523_C9996_DOC_EN_14084.pdf
