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Shaguar, Signature Signergy and counterfeit VIGRX (green capsule), VIGRX (white capsule), VigRx, and VigRX Plus

Starting date:
December 16, 2010
Posting date:
July 30, 2013
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-120001376

Last updated:

Updated July 30, 2013

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.

Health Canada has become aware of new information provided to the New Zealand Medicines and Medical Devices Safety Authority (MedSafe), confirming that the adulterated VigRX and VigRX Plus samples seized and tested by MedSafe in 2010 were counterfeit products. Health Canada is not aware of any affiliation between these products and the VigRX and VigRX Plus products from DM Contact Management currently authorized for sale in Canada.

Source of alert

New Zealand's MedSafe

Product names

  • Shaguar
  • Signature Signergy 
  • VIGRX (green capsule)
  • VIGRX (white capsule)
  • VigRx
  • VigRX Plus

Manufacturer / Place of origin

Unknown

Product description

These products are promoted for the enhancement of sexual performance or the treatment of erectile dysfunction.

Reason for warning

New Zealand's MedSafe warned consumers to not buy or use these products after they were found to contain undeclared sildenafil, hydroxyhomosildenafil, thiosildenafil, and/or tadalafil, as follows.

Products with Undeclared Medicines
Product Name Undeclared medicine (dose) Content
Shaguar Tadalafil (20 mg) Caplet
Signature Signergy Thiosildenafil (63 mg) and hydroxyhomosildenafil (3 mg) Capsule contents
Thiosildenafil (4 mcg ) Capsule shell
VIGRX (counterfeit)
(green capsule)
Sildenafil (90 mg) Capsule (green)
Sildenafil (5 mg) Tablet (black)
VIGRX (counterfeit)
(white capsule)
Sildenafil (65 mg) Capsule (white)
Sildenafil (2 mcg ) Tablet (black)
VigRx (counterfeit) Sildenafil (140 mg) Tablet
VigRX Plus (counterfeit) Sildenafil (0.3 mg) and tadalafil (0.1 mg) Caplet

Sildenafil and tadalafil are prescription drugs used to treat erectile dysfunction and should only be taken under the supervision of a health care practitioner. Hydroxyhomosildenafil and thiosildenafil are unauthorized substances similar to sildenafil and may pose similar health risks.

According to the MedSafe news release, the six products are being promoted and sold in New Zealand by various retailers, including "adult" shops, and over the Internet. Medsafe ordered the recall of all batches of these products from the New Zealand market.

Possible side effects

Sildenafil and tadalafil should not be used by individuals taking any kind of nitrate drug (e.g., nitroglycerine) as they 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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For more information

Product specific information on drugs and natural health products approved for use in Canada can be found in the following databases on the Health Canada website: