SLIMDIA Revolution: Public Notification - Contains Undeclared Drug Ingredient Sibutramine
UPDATED 12/21/2012 P&J Trading announced today that it is conducting a voluntary nationwide recall of the company's dietary supplements sold under the brand name SLIMDIA REVOLUTION after being notified by FDA that testing found the SLIMDIA REVOLUTION products contain Sibutramine
ISSUE: FDA is advising consumers not to purchase or use “SLIMDIA Revolution,” a product promoted and sold for weight loss on various websites, including www.pinkfatty.com, and in some retail stores.
FDA laboratory analysis confirmed that “SLIMDIA Revolution” contains Sibutramine.
BACKGROUND: Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses 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. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
RECOMMENDATION: Consumers should stop using this product immediately and throw it away. Consumers who have experienced any negative side effects should consult a health care professional as soon as possible.
Health care professionals and patients are encouraged to report adverse events or side effects related to the use of these products to FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- 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
[12/19/2012 - Press Release - P&J Trading]
[12/20/2012 - Public Notification - FDA]