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FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
Contact:
Zhen De Shou product recall
Fashionsanctuary.com
PO Box 19369
San Diego, CA 92159
zhendeshourecall@gmail.com
FOR IMMEDIATE RELEASE --San Diego, CA -- November 23, 2008 --- Fashion Sanctuary is recalling all lot codes of Zhen De Shou Fat Loss Capsules sold in 10 count blister cards. The recall was initiated after notification by the Food and Drug Administration (FDA) that lab analysis of Zhen De Shou samples found the product to contain undeclared sibutramine, making it an unapproved drug. Sibutramine is an FDA approved drug used as an appetite suppressant for weight loss. This poses a potential 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.
The product was primarily distributed in the U.S and sold via the Internet. It is sold in a box with an inner foil pouch. Inside the pouch is a blister pack containing light and dark green capsules. This recall affects all lot codes and use by dates. No illnesses or injuries have been reported to date in connection with this product.
Consumers who may have purchased product from this company should immediately discontinue using the product and contact the firm at zhendeshourecall@gmail.com to receive further instructions for returning the product or with any questions.
We sincerely regret any inconvenience to consumers. The firm has taken this voluntary action out of concern for the health and safety of consumers.
This recall is being made in cooperation with the US Food and Drug Administration.
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/medwatch.
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