Classic Zi Xiu Tang Bee Pollen Capsules And Ultimate Formula Capsules by Zi Xiu Tang Success: Recall - Undeclared Sibutramine
ISSUE: TZi Xiu Tang Success, LLC is voluntarily recalling four lots of Classic Zi Xiu Tang Bee Pollen Capsules, and three lots of Ultimate Formula Capsules to the consumer level. These products have been found to contain undeclared Sibutramine. Sibutramine was 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.
Products containing Sibutramine 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. These products may also interact in life threatening ways with other medications a consumer may be taking. The company has not received any reports of adverse events related to this recall. The recall was initiated after discovering that Sibutramine was included as an ingredient by the manufacturer.
BACKGROUND: The Classic Zi Xiu Tang Bee Pollen product is marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of 60 capsules. The affected Classic Zi Xiu Tang with UPC 6937000700019, includes the following lot numbers - lots 04/15/2012, 05/15/2012, 06/15/2012 and 07/15/2012. Classic Zi Xiu Tang was distributed Nationwide to consumers and distributors. The products were distributed from May 1, 2012 to October 17, 2012.
The Ultimate Formula product is also marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of 48 capsules. The affected Ultimate Formula with UPC 793573041401, includes the following lot numbers – 05/25/2012, 07/29/2012 and 08/05/2012. The Ultimate Formula was distributed Nationwide to consumers and distributors. The products were distributed from May 1, 2012 to October 17, 2012.
RECOMMENDATION: Zi Xiu Success, LLC is notifying its distributors and customers by letter and is arranging for return of all recalled products. Consumers and distributors that have product which is being recalled should stop using the products and return the product to Zi Xiu Success, LLC. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of this product 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
[10/31/2012 - Press Release - Zi Xiu Tang Success, LLC]