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 Foreign Product Alert - October 17, 2010 - OxyELITE Pro capsules (often promoted as Oxy Elite Pro capsules)
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