AUDIENCE: Consumer, Patient, Health Professional
ISSUE: CTV Best Group announced that it is conducting a voluntary nationwide recall of all lots of a dietary supplement products distributed by the company under the names BEST SLIM 40 Pills to the consumer level. Testing by FDA revealed the presence of Sibutramine in Best Slim. Sibutramine has been withdrawn from U.S marketplace and is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. The active drug ingredient is not listed on the label for this product.
BACKGROUND: Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the U.S. market in October 2010 for safety reasons, making this product an unapproved new drug. The products were distributed nationwide via retail stores and internet sales via WWW.Bestslim.net between April 2013 and July 2013. All lots of the Best Slims 40 pills, Lot # 109400 EXP: Dec. 31, 2016.
RECOMMENDATION: Customers with stock of the recalled product should destroy it or return for a refund, and should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product. Consumers who have the recalled product in their possession should stop using the products immediately and can call (888) 417-2667 Monday through Friday between 10 a.m. and 6p.m. EST for further information.
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
[08/03/2013 - Firm Press Release - CTV BEST GROUP]