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Pai You Guo, Marketed as Dietary Supplement - Recall
Audience: Consumers
GMP Herbal Products and FDA notified consumers and healthcare professionals of a recall of Pai You Guo, a weight loss dietary supplement, due to the presence of undeclared drug ingredients. FDA lab analyses of dietary supplements were found to contain undeclared sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss; and phenolphthalein, a solution used in chemical experiments and a suspected cancer-causing agent that is not approved for marketing in the United States. The FDA has not approved the Pai You Guo products as a drug; therefore the safety and effectiveness of this product is unknown. The product is sold either in a box of 30 capsules or a bag of 10 g powder. The affected products were sold and distributed nationwide via the internet.
FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke.
Consumers are advised to destroy the affected products or return them to the company’s address in Westminster, CA.
Read the complete MedWatch 2009 Safety summary, including a link to the firm press release at:
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GovDelivery, Inc. sending on behalf of U.S. Food & Drug Administration (FDA) · 5600 Fishers Lane · Rockville MD 20857 · 800-439-1420
