Fwd: Pai You Guo, Marketed as Dietary Supplement - Recall: Weight loss product contains undeclared drug ingredients sibutramine and phenolphthalein

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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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