ISSUE: Dolphin Intertrade Corp. is voluntary recalling “JaDera” and “Xiyouji Qingzhi” Weight Loss Supplement. These product have been found to contain undeclared Sibutramine, 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.
BACKGROUND: JaDera Weight Loss Supplement is marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of # 30 capsules. The affected JaDera Weight Loss Supplement, includes manufactured lot 10.06.2011 with Expiration Date: 09.06.2013. JaDera Weight Loss Supplement was distributed Nationwide to consumers and distributors. The products were distributed from May 2011 to May 2013.
RECOMMENDATION: Consumers and distributors that have product which is being recalled should stop using the products and return the product to Dolphin Intertrade Corp. 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.
- 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.