Foreign Product Alerts: Albuterex Xtreme Formula, Albutarex Xtreme and Albutarex Femme Formula

Starting date:
August 7, 2013
Posting date:
August 7, 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-34863
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

Albuterex Xtreme Formula
Albutarex Xtreme
Albutarex Femme Formula

Product description

These products are promoted for weight loss.
Hazard identified

The Australian Therapeutic Goods Administration has warned consumers not to use these products after they were found to contain undeclared drug ingredients and high undeclared amounts of caffeine.

Albuterex Xtreme Formula was found to contain theophylline, yohimbine and caffeine.
Albutarex Xtreme and Albutarex Femme Formula were found to contain theophylline and caffeine.
Yohimbine is a prescription drug used to treat abnormal blood pressure. It should only be taken under the supervision of a health care practitioner.
Theophylline is a prescription drug used to treat asthma and bronchitis. It should only be taken under the supervision of a health care practitioner.
Caffeine, as a natural health product ingredient, is used to promote alertness and endurance, to enhance cognitive and motor performance, and to promote diuresis.

Place of origin

The distributor of Albuterex Xtreme Formula, Albutarex Xtreme, and Albutarex Femme Formula is "Nutri-Sups Worldwide Distribution Pty Ltd"
Side effects

Side effects associated with yohimbine include abnormal blood pressure and heartbeat, anxiety, tremors, headache, nausea and sleep disorders.


Side effects associated with theophylline include stomach pain, bloody stools, fast or irregular heartbeat, fast breathing, headache, restlessness, muscle twitching, and convulsions (seizures).

Side effects associated with caffeine include rapid and irregular heart rate, increased blood pressure, insomnia, restlessness, anxiety, nervousness, tremor, and headache.

Additionally, the combined use of yohimbine, theophylline, and caffeine may be harmful, as these ingredients are associated with stimulant effects.
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 product listed above in the Canadian marketplace.

Canadians who have this product are advised not to use it, and should consult with a health care practitioner if they have concerns about their health related to the use of this product.
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. Some products may also still have an Exemption Number (EN).

Health Canada has allowed a transition period for industry to move natural health products through the market that were labelled with temporary EN numbers.