Svelte 30: Recall - Undeclared Drug Ingredient
Audience: Consumer
ISSUE: FDA lab analysis of Svelte 30 orange & gray capsules determined that the product contains Sibutramine, an FDA-approved drug used as an appetite suppressant for weight loss. The FDA has not approved Svelte 30 orange & gray capsules as drugs; therefore the safety and effectiveness of this product is unknown. This product may 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.
BACKGROUND: Svelte 30 orange & gray capsules are marketed as a natural herb for weight loss. Svelte 30 Herb Supplement is packaged in plastic bottles containing 30 capsules per bottle and bears UPC #’s from 04-3000 to 04-5999. Were MFD: 10/22/2010 with EXP: 10/21/2012.
RECOMMENDATION: Consumers should return the affected product immediately to the place of purchase for a refund.
Healthcare professionals and patients are encouraged to report adverse events, side effects, or product quality problems related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.accessdata.fda.gov/scripts/medwatch/index.cfm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
[02/09/2011 - Press Release - Svelte 30 Nutritional Consultants]
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