Foreign Product Alerts: Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator

Starting date:
July 16, 2014
Posting date:
July 16, 2014
Type of communication:
Foreign Product Alert (FPA)
Subcategory:
Natural health products
Source of recall:
Health Canada
Source of alert:

United States Food and Drug Administration (FDA)

Issue:
Undeclared Substance
Audience:
General Public
Identification number:
RA-40533

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

  • Bella Vi Insane Bee Pollen Capsules
  • Bella Vi BTrim Ultimate Boost
  • Bella Vi BTrim Max
  • Bella Vi Extreme Accelerator

Bella Vi Insane Bee Pollen Capsules, Bella Vi BTrim Ultimate Boost, Bella Vi BTrim Max, Bella Vi Extreme Accelerator

Product description

These products are promoted for weight loss. Affected products were packaged as follows:
Product Name Description Lot and Expiration
Bella Vi Insane Bee Pollen Capsules 60 capsule bottle lot # 201303 EXP: 2014/03/07
Bella Vi BTrim Max 60 capsule bottle lot # BTX13 EXP: 2015/08/15
Bella Vi BTrim Ultimate Boost 30 capsule bottle lot # BTRM3452 EXP: 2015/07/03
Bella Vi Extreme Accelerator 30 capsule bottle lot # BTRX7654 EXP: 2015/07/08

Hazard identified

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

  • Sibutramine was previously used to treat obesity but is no longer authorized for sale in Canada because of its association with an increased risk of cardiovascular side effects such as heart attack and stroke.
  • Phenolphthalein was previously used as a laxative but is no longer authorized for sale in Canada because it may cause cancer.

Place of origin

Distributed by Pure Edge Nutrition, LLC (Toms River, New Jersey)

Side effects

In addition to heart attack and stroke, side effects associated with sibutramine include increased blood pressure and heart rate, dry mouth, difficulty sleeping and constipation.

Additional side effects associated with phenolphthalein include decreased blood pressure, skin rash and gastrointestinal bleeding.

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 these 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 May 15, 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