**Update** Atlas Operations Inc. expands its U.S. recall of over 30 sexual enhancement supplements (see Foreign Product Alert for an updated list or recalled products)

Foreign Product Alert
2010-120
July 14, 2010
For immediate release

Health Canada is advising consumers not to use the products specified below due to concerns about possible side-effects. More info

Source of Alert

U.S. Food and Drug Administration

Product Names

** This is an update to a previous Health Canada Foreign Product Alert **

The U.S. distributor Atlas Operations Inc. issued a revised and expanded list of products recalled in the U.S.  

The revised list includes new products (Erectzia and Vigor 100) and additional lots of previously recalled products (72 Hours, Enhancement, Ezerex, Libiplus, Stamin It, Vaxitrol, and Zenerect). Some product names have also been corrected and/or clarified by the company.

The list of recalled products (which includes the products listed in the previous Health Canada Alert) is provided here:

Product Name		Lot Number(s) ***
1.	72 Hours (all strengths)	###-705-##
		###-706-##
2.	Amour Again for Him	###-705-##
3.	APL	###-705-##
4.	Arousin	###-705-##
5.	Aspire One	###-494-##
6.	Bulk-Unlabelled (i.e. no product name)	###-705-##
7.	Clyamax	###-705-##
8.	Depth Charge	###-807-##
9.	Enhancement	###-705-##
		###-706-##
10	Erectzia	###-705-##
11.	Erexa	###-705-##
12.	Ere-xxx by Elite Body	###-705-##
13.	Ere-xxx by Maxi Elit	###-705-##
14.	Erousa	###-705-##
15.	Ezerex	###-705-##
		###-706-##
16.	Finally on Demand	###-706-##
17.	Libiplus	###-705-##
		###-520A-##
		###-520B-##
18.	Love Fuel	###-520A-##
		###-520B-##
		###-706-##
19.	Love Fuel 2	###-521-##
20.	Rainbow Rocket	###-706-##
21.	Red Hot Sex	###-705-##
22.	Rockhard	###-705-##
23.	Sex Enhancer	###-520C-##
24.	Sexual Surge	###-520A-##
		###-520B-##
		###-705-##
25.	Stamin It	###-520A-##
		###-520B-##
		###-705-##
26.	Staminil	###-520A-##
		###-520B-##
		###-705-##
27.	Tacktol	###-705-##
28.	Topviril	###-705-##
29.	Vaxitrol	###-520-##
		###-520A-##
		###-520B-##
		###-520C-##
30.	Vierect	###-705-##
31.	Vigor 100	###-705-##
32.	Whatz Up Rx	###-706-##
33.	Xtremexcite	###-706-##
34.	Zenerect	###-705-##
		###-779-##

***Lot numbers may or may not contain dashes. The first three and last two digits and letters are insignificant.

Manufacturer / Place of Origin

Atlas Operations Inc. of  Pompano Beach, Florida, U.S.

Product Description

The products listed above are promoted as dietary supplements used for sexual enhancement.

All products come in capsule form and may be packaged in blisters, pouches or bottles.

Reason for Warning

The U.S. FDA informed consumers of an expanded recall of certain lots of the products listed above after some were found to contain undeclared sulfoaildenafil. The products are being voluntarily recalled nationwide in the U.S. by the company Atlas Operations Inc.

Sulfoaildenafil is an unauthorized substance similar to sildenafil and may pose similar health risks. Sildenafil is a prescription drug used to treat erectile dysfunction. It should only be used under the supervision of a health care practitioner.

According to the company-issued news release, consumers who have purchased these products are urged to discontinue their use and return them to their place of purchase.  Products may also be returned directly to Atlas Operations by calling 1-800-466-4444 Monday through Friday from 9:00 am - 5:00 pm EST for instructions on the return and refund process.

As noted above, Health Canada issued a previous Foreign Product Alert regarding this recall.

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.

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Media Enquiries:
Health Canada
(613) 957-2983

For more details on these Foreign Product Alerts, please visit the Health Canada Web site.

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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.

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.

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.

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.

For more information about the information contained in this advisory, please contact Health Canada's public inquiries line at (613) 957-2991 or toll-free at 1-866-225-0709.

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.