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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
What you should do
Report health or safety concerns
Related AWRs
Media enquiries
Public enquiries
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
| 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
- Foreign Product Alert - October 17, 2010 - OxyELITE Pro capsules (often promoted as Oxy Elite Pro capsules)
What you should do
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- 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
Related AWRs
Media enquiries
Health Canada
(613) 957-2983
Public enquiries
(613) 957-2991
1-866 225-0709