Archived – Rose 4 Her

Starting date:

September 19, 2008

Posting date:

September 19, 2008

Type of communication:

Foreign Product Alert (FPA)

Subcategory:

Natural health products

Source of recall:

Health Canada

Issue:

Important Safety Information, Undeclared Substance

Audience:

General Public

Identification number:

RA-12000543

• Media enquiries
• Public enquiries

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

Rose 4 Her

Manufacturer / Place of origin

Jack Distribution, LLC / Florida, U.S.A.

Product description

• Rose 4 Her is promoted as an all-natural product used for female sexual enhancement.
• Rose 4 Her capsules are packaged in single blister packs and three count bottles.

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Reason for warning

The U.S. Food and Drug Administration warned against the use of Rose 4 Her capsules because the product was found to contain thiomethisosildenafil, a compound similar in structure to sildenafil. The product has been voluntarily recalled by the manufacturer in the U.S.

Sildenafil is a prescription drug used in the treatment of erectile dysfunction, and should only be taken under the supervision of a health care professional.

Possible side effects

• Unsupervised use of sildenafil by patients with heart disease can result in serious cardiovascular side effects such as sudden cardiac death, heart attack, stroke, hypertension, chest pain and abnormal heartbeat.
• Additionally, use of sildenafil may be associated with other side effects including temporary vision loss, seizure, prolonged erection, headache, flushing, nasal congestion and abdominal pain.
• Sildenafil should not be used by individuals taking any type of nitrate drug (e.g., nitroglycerine) due to the risk of developing potentially life-threatening low blood pressure.

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