AUDIENCE: Consumer, Health Professional
ISSUE: B@B Trade, Inc., Florida is voluntarily recalling all lots of Slim Fortune, Lidiy, and Slim Expert to the consumer level. The FDA laboratory analysis of these dietary supplements found to contain undeclared Sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, making these products unapproved new drugs. These products 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. This product may also interact, in life-threatening ways, with other medications a consumer may be taking.
BACKGROUND: These products are marketed as a natural herb for weight losl and are packaged in plastic bottles as follows: Slim Fortune green capsules/30 capsules per bottle, Lidiy green capsules,/30 capsules per bottle, and Slim Expert 30 softgels capsules per bottle. The products were sold directly to individual customers in our Florida, sales office and online at www.lidiy.com, www.slimfortune.com, or www.slimexpert.com.
RECOMMENDATION: Consumers should not consume Slim Fortune, Lidiy, or Slim Expert Dietary Supplements and should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product. Consumers should return the products immediately to the place of purchase. Consumers with questions should contact B@B Trade Inc. at 305-763-6956 or via e-mail at email@example.com Monday - Friday, 10:00 am - 4:00 pm, EDT.
Healthcare professionals and patients are encouraged to report adverse events or side effects 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.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
[10/07/2013 - Press Release - B @ B Trade Inc.]