GMP Herbal Products, Inc. has been informed by the Food and Drug Administration (FDA) that Pai You Guo, a weight loss dietary supplement, sold and marketed by the firm contains undeclared drug ingredients.
FDA lab analyses of dietary supplements distributed by the company 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 drug; therefore the safety and effectiveness of this product is unknown. All lots of the following Pai You Guo product are being recalled. The product is sold either in a box of 30 capsules or a bag of 10 g powder.
The products listed above 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.
No illnesses or injuries have been reported to the company to date in connection with this product.
GMP Herbal Products, Inc. has taken this voluntary action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. GMP Herbal Products, Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers are advised to destroy the above products or return them to the company’s address in Westminster, CA. Consumers with questions may contact GMP Herbal Products, Inc Tuesday through Saturday 11:00 am to 7:00 pm at 1-866-995-8585.
Any adverse reactions experienced with the use of this product should also be reported to the FDA’s MedWatch Program by phone at 1-800-FDA-1088, by fax at 1-800-FDA-0178, by mail at MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787, or on the MedWatch website at wwww.fda.gov/Safety/MedWatch/default.htm.