Recall -- Firm Press Release
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Urgent Supplement Recall
Dolphin Intertrade Corp.
11314 SW 135 CT. Miami, FL 33186 USA
FOR IMMEDIATE RELEASE - May 21, 2013 - Miami, Florida 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.
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.
Dolphin Intertrade Corp. 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 Dolphin Intertrade Corp.
Consumers with questions regarding this recall can contact Dolphin Intertrade Corp. at 305-383-7600 Monday - Friday from 9:00am-5:00pm EST. 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.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
• Online: www.fda.gov/medwatch/report.htm11
• Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: www.fda.gov/MedWatch/getforms.htm22. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Recalled Product Photos Are Also Available on FDA's Flickr Photostream.