Foreign Product Alerts: Prolifta Capsules, PHUK and Virilis Pro

Starting date:
May 28, 2014
Posting date:
May 28, 2014
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Drugs
Source of recall:
Health Canada
Source of alert:

US FDA

Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-39623

Introduction

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.

Affected products

  • Prolifta Capsules
  • PHUK
  • Virilis Pro

Prolifta Capsules, PHUK, and Virilis Pro

Product description

These products are promoted for sexual enhancement.

  • Prolifta Capsules are packaged in 1- and 2-capsule blister packs and 4-, 12- and 24-capsule bottles.
  • Virilis Pro is packaged in 1- and 2-capsule blister packs and 10-capsule bottles.
  • PHUK is packaged in 1- and 2-capsule blister packs and 4-, 12- and 24-capsule bottles.

Hazard identified

The United States Food and Drug Administration (US FDA) warned consumers not to use these products after they were found to contain undeclared sildenafil.

Sildenafil is a prescription drug used to treat erectile dysfunction. It should only be taken under the supervision of a healthcare professional.

Place of origin

Haute Health LLC

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.

In addition, individuals with heart problems are at increased risk of cardiovascular side effects such as heart attack, stroke, chest pain, high blood pressure and abnormal heartbeat.

Other side effects include headache, facial flushing, indigestion, dizziness, abnormal vision, and hearing loss.

What you should do

Health Canada advises Canadians to contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if they find the products listed above in the Canadian marketplace.

Canadians who have these products are advised not to use them, and should consult with a healthcare professional if they have concerns about their health related to the use of the products.

Background

Drugs and natural health products that are authorized for sale in Canada will have 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 April 30, 2014, no adverse reactions suspected to be associated with the use of these products have been reported to Health Canada.

Report a health or safety concern

To report a side effect to a health product to Health Canada:

  • 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.