JaDera and Xiyouji Qingzhi Dietary Supplements by Dolphin Intertrade Corp.: Recall - Undeclared Drug Ingredient
Fri, 28 Jun 2013 13:30:00 -0400
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.
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: 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.
Xiyouji Qingzhi Weight Loss Supplement is marketed as a dietary supplement used as a weight loss aid and is packaged in bottles of # 30 capsules of 300mg. The affected Xiyouji Qingzhi Weight Loss Supplement, includes all lots. 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.
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.