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Unauthorized weight loss products OxyElite Pro linked to multiple reports of serious liver injury in the U.S.

Starting date:
November 15, 2013
Posting date:
November 15, 2013
Type of communication:
Information Update
Subcategory:
Drugs
Source of recall:
Health Canada
Issue:
Important Safety Information
Audience:
General Public
Identification number:
RA-36785

Issue

Health Canada is advising Canadians of a U.S. Food and Drug Administration (FDA) warning not to use dietary supplements labelled as “OxyElite Pro” following several U.S. reports of serious liver injury. Certain OxyElite Pro dietary supplements are being recalled by the distributor, USPLabs LLC of Dallas, Texas (see list below). 

OxyElite Pro products, which are promoted for rapid weight loss, are not authorized in Canada and have not been found on the Canadian market. However, they are widely available in the U.S. and over the Internet. Canadians may have purchased these products while shopping online or travelling. To date, no adverse reactions have been reported to Health Canada involving OxyElite Pro.

Several dozen U.S. cases of liver damage have so far been potentially linked to OxyElite Pro, including at least one case resulting in a liver transplant, and one death. Symptoms of liver injury can include fever, fatigue, loss of appetite, nausea, vomiting, abdominal pain, dark urine, clay or gray-colored bowel movements, joint pain, yellow eyes, and jaundice.

The U.S. FDA and the Centre for Disease Control are continuing their investigation regarding OxyElite and the reports of hepatic adverse reactions

Affected products
Company Name Product Name Amount UPC#
USPLabs LLC of Dallas, Texas OxyElite Pro Super Thermo capsules two count capsules 094922417275
10 count capsules 094922417251
10 count capsules 094922417268
21 count capsules 094922426604
90 count capsules 094922395573
90 count capsules "Pink label" 094922447906
180 count capsules 094922447852
OxyElite Pro Ultra-Intense Thermo capsules three count capsules 094922447883
three count capsules 094922447876
90 count capsules 094922395627
180 count capsules 094922447869
OxyElite Pro Super Thermo Powder Fruit Punch 0.15 oz 094922417237
Fruit Punch 0.15 oz 094922447517
Fruit Punch 4.6 oz 094922426369
Fruit Punch 5 oz. 094922447487
Blue Raspberry 4.6 oz 094922426376
Grape Bubblegum 4.6 oz 094922447500
Green Apple 4.6 oz. 094922426499

What you should do

  • Do not use OxyElite Pro products and consult with a healthcare professional if you experience symptoms of liver injury or other health concerns related to their use.
  • Contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if you find OxyElite Pro products in the Canadian marketplace.
  • Use only health products that have been evaluated by Health Canada for safety, effectiveness, and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.

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 MedEffect Canada's Web page on Adverse Reaction Reporting for information on how to report online, by mail or by fax

Previous Advisories, Warnings and Recalls

What you should do

  • Do not use OxyElite Pro products and consult with a healthcare professional if you experience symptoms of liver injury or other health concerns related to their use.
  • Contact the Health Products and Food Branch Inspectorate at 1-800-267-9675 if you find OxyElite Pro products in the Canadian marketplace.
  • Use only health products that have been evaluated by Health Canada for safety, effectiveness, and quality. Health products that have been authorized for sale by Health Canada will have an eight-digit Drug Identification Number (DIN), a Homeopathic Medicine Number (DIN-HM) or a Natural Product Number (NPN) on the label.

Report health or safety concerns

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

  • Call toll-free at 1-866-234-2345
  • Visit MedEffect 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