Foreign Product Alerts: Various sexual enhancement products

Starting date:
February 7, 2014
Posting date:
February 7, 2014
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Source of alert:

 Food and Drug Administration

Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-37719

Introduction

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.

Affected products

  • Cave Diver
  • Clalis
  • Exten 1300
  • Get It Up
  • MaxTreme Zen
  • MVP Mega
  • Nights to Remember
  • Reload
  • Royal Dragon Herbal Tonic Balls
  • Silver Sword
  • Super Cheetah
  • X Zen Platinum

Cave Diver, Clalis, Exten 1300, Get it Up, MaxTreme Zen, MVP Mega, Nights to Remember, Reload, Royal Dragon Herbal Tonic Balls, Silver Sword, Super Cheetah, and X Zen Platinum

Product description

These products are promoted for sexual enhancement.

Hazard identified

The U.S. Food and Drug Administration warned consumers not to use these products after they were found to contain drug ingredients that were not declared on the label.

  • Cave Diver, Clalis, Get It Up, Nights to Remember, Reload, Silver Sword, and Super Cheetah contain sildenafil.
  • MVP Mega contains tadalafil.
  • Exten 1300, X Zen Platinum, and MaxTreme Zen contain sildenafil and tadalafil.
  • Royal Dragon Herbal Tonic Balls contains vardenafil.
  • Sildenafil, tadalafil and vardenafil are prescription drugs used to treat erectile dysfunction.  They should only be taken under the supervision of a healthcare professional.

Place of origin

  • Cave Diver and Super Cheetah are distributed by Boscolini LLC (Chicago, Illinois, U.S.A)
  • Clalis and Silver Sword are distributed by Hardmenstore.com (Fort Lauderdale, Florida, U.S.A)
  • Exten 1300 is distributed by Exten 1300 mega Inc. (Beverly Hills, California, U.S.A.)
  • MaxTreme Zen is distributed by Biotech Power Inc.(San Diego, California, U.S.A)
  • MVP Mega is distributed by MVP mega Inc. (Beverly Hills, California, U.S.A)
  • Nights to Remember is distributed by Smartcense Wholesale Solutions (Monroeville, Pennsylvania, U.S.A)
  • For Get It Up, Reload, Royal Dragon Herbal Tonic Balls, and X Zen Platinum, the origin is unknown.

Side effects

Sildenafil, tadalafil and vardenafil should not 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 are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat.  Other side-effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

What you should do

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.

Canadians who have these products are advised not to use them, and should consult with a health care practitioner if they have concerns about their health related to the use of these products.

Background

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.

As of December 31, 2013, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Report a health or safety concern

To report a side effect to a health product to Health Canada:

  • 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

Images

Select thumbnail to enlarge - opens in a new window