GMP Herbal Products Recalls Pai You Guo Weight Loss Supplement

GMP Herbal Products, Inc. has been informed by the 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 not approved for marketing in the U.S. The FDA has not approved the Pai You Guo products as a drug, therefore the safety and effectiveness of this product is unknown.

Therefore, all lots of Pai You Guo are being recalled. The product is sold either in a box of 30 capsules or a bag of 10 g of powder. The products were sold and distributed nationwide via the Internet.

The FDA advises that these products pose a threat to consumers because sibutramine is known to substantially increase blood pressure and 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.

Consumers should destroy the recalled products in their possession or return them to the company. To obtain more information about returning the products or to gets answers to questions they may have, consumers should contact the company Tuesday through Saturday from 11 a.m. until 7 p.m. at 866-995-8585. 

Any adverse reactions experienced with the use of Pai You Guo should also be reported to the FDA's MedWatch Program:

• By phone: 800-FDA-1088
• By fax: 800-FDA-0178
• By postal mail: MedWatch, FDA, 5600 Fishers Lane, Rockville, MD 20852-9787
• Online: wwww.fda.gov/Safety/MedWatch/default.htm

Contact:
Mike Le
866-995-8585