Firminite, Extra Strength Instant Hot Rod, Libidron

Starting date:

August 1, 2012

Posting date:

August 1, 2012

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Undeclared Substance, Product Safety

Audience:

General Public

Identification number:

RA-14996

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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.

Source of alert

U.S. Food and Drug Administration

Product names

• Firminite
• Extra Strength Instant Hot Rod
• Libidron

Manufacturer / Place of origin

West Coast Nutritionals Ltd.

Product description

These products are promoted for sexual enhancement.

Firminite

Firminite is sold in two- four- and ten-count individual boxes, and in various kits and packs including:

• Intro Pack
• Tester Pack
• Economy Stimulus Pack
• Super Performance Pack
• Super Savings Pack

Extra Strength Instant Hot Rod

Extra Strength Instant Hot Rod is sold in four- and ten-count individual boxes and in various kits and packs, including:

• Intro Special
• Tester Pack
• Silver Elite Special Pack
• Gold Elite Special Pack
• Platinum Elite Pack
• Super Savings Elite Pack

Libidron

Libidron is sold in two- four- and ten-count individual boxes, and in various kits and packs including:

• Intro Special
• Tester Pack
• Elite Silver Pack
• Elite Gold Pack
• Ultimate Performance Pack
• Ultimate Savings Pack

Reason for warning

The U.S. Food and Drug Administration (FDA) informed consumers of a company recall after these products were found to contain undeclared tadalafil.

Tadalafil is a prescription drug used to treat erectile dysfunction and should only be taken under the supervision of a health care practitioner.

According to the company press release, the products may have been ordered online at www.firminite.com; www.instanthotroddextrastrenght.com; www.libido.com and the Amazon Web site and were distributed to customers and retailers nationwide in the U.S. and worldwide. The press release also states that the U.S. FDA is aware of one consumer complaint with an adverse event.

Possible side effects

Tadalafil should not be used by individuals taking any kind of nitrate drug (such as 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 heart beat. Other side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

What you should do

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.

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

Background

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.

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.

Report a health or safety concern

• 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.

Media enquiries

Health Canada
613-957-2983

Public enquiries

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

Images

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