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Prolatis' and Duro Extend Capsules For Men

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:
Unauthorized products, Undeclared Substance, Product Safety
Audience:
General Public
Identification number:
RA-120001537

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

Prolatis' and Duro Extend Capsules For Men

Manufacturer / Place of origin

Prolatis' is distributed by Prolatis', Salt Lake City, Utah, U.S.

Duro Extend Capsules For Men is manufactured by Intelli Health Products, Miami, Florida, U.S.

Product description

These products are promoted for the treatment of erectile dysfunction.

Prolatis' is sold in double blister packs and in bottles containing 40 capsules.

Duro Extend Capsules For Men are sold individually as a blister pack containing one capsule per unit, in display boxes containing 12 or 24 blister packs, and in bottles containing 3 or 10 capsules.

Reason for warning

The U.S. FDA informed consumers that these products are being recalled in the U.S. because they were found to contain undeclared sulfoaildenafil, which is an unauthorized substance similar to sildenafil and may pose similar heath risks. Lots of Prolatis' manufactured prior to August 9, 2010 are being voluntarily recalled by the company Prolatis', while Duro Extend Capsules For Men is being voluntarily recalled by Intelli Health Products.

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 the companies directly:

  • Prolatis' (Prolatis'): 1-877-286-5056
  • Intelli Health Products (Duro Extend Capsules For Men): 1-800-861-6022

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


Images

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