Diet Supplement Recalled For Undeclared Drug
Shaping Beauty, Inc. has been informed by the Food and Drug Administration (FDA) that a weight loss dietary supplement sold and marketed by the firm contain an undeclared drug ingredient. FDA lab analyses of dietary supplements distributed by the company were found to contain undeclared Sibutramine used as an appetite suppressant for weight loss.
The FDA has not approved the following products as drugs; therefore the safety and effectiveness of this product is unknown. All lots of the following dietary supplement products are being recalled:
CELERITE™ SLIMMING CAPSULES
The products listed above were sold and distributed nationwide via the internet at www.shapingbeauty.com
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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. Shaping Beauty, Inc. has taken this action because it is committed to providing accurate information about its products and because of the concern for the health and safety of consumers. Shaping Beauty, Inc. is working with the FDA in the recall process. It sincerely regrets any inconvenience to customers.
Consumers are advised to return the product to the company’s address in Southampton, PA Consumers with questions may contact Shaping Beauty, Inc. Monday through Friday 9:00 am to 5:30 pm at 1-800-728-2850
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.htm210.