Aziffa, Erex, Eyeful, Hard Drive, Libidinal, Maxyte, Mojo, Monster Excyte, OMG, OMG45, Prolatis, Red Magic, Size Matters, Stiff Nights, Straight Up, Verect, WOW, Xaitrex, Xytamax, Zilex (with Golden Spear) and Zotrex

Starting date:

January 31, 2011

Posting date:

January 31, 2011

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Product Safety, Undeclared Substance

Audience:

General Public

Identification number:

RA-120001509

• Related AWRs

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 (FDA)

Product names

• Aziffa
• Erex
• Eyeful
• Hard Drive
• Libidinal
• Maxyte
• Mojo
• Monster Excyte
• OMG
• OMG45
• Prolatis
• Red Magic
• Size Matters
• Stiff Nights
• Straight Up
• Verect
• WOW
• Xaitrex
• Xytamax
• Zilex (with Golden Spear)
• Zotrex

Manufacturer / Place of origin

Novacare LLC, Salt Lake City, Utah, U.S.

Product description

These products are promoted for sexual enhancement and come packaged in bottles and/or "blister cards".

Reason for warning

The U.S. FDA informed consumers that these products are being recalled in the U.S. because they appear to contain undeclared sulfoaildenafil, which is an unauthorized substance similar to sildenafil and may pose similar heath risks. All lots of the above-named products with manufacture or distribution dates prior to June 17, 2010 are being voluntarily recalled by Novacare LLC.

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

Consumers wishing for more information on the recalls can contact Novacare LLC directly by calling 801-290-1738.

Health Canada has communicated in the past about products with the same name (but that are not necessarily the same products): Prolatis' and Stiff Nights.

Possible side effects

Sildenafil 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 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

Related AWRs

Canadians Advised Not to Use Stiff Nights or Any Unauthorized Product Promoted for Erectile Dysfunction

2010-01-08 | Health products

Advisory

Prolatis' and Duro Extend Capsules For Men

2011-01-31 | Health products

Advisory

Unauthorized dangerous health products found at Calgary retailer

2013-05-30 | Health products

Advisory