Products found to contain undeclared medicines
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| The United States: Dream Body Weight Loss issues voluntary nationwide recall of Dream Body 450mg, Dream Body Extreme Gold 800mg, Dream Body Advanced 400mg due to undeclared sibutramine |
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The U.S. Food and Drug Administration (FDA) announced that Grand Prairie, TX, Dream Body Weight Loss is voluntarily recalling all lots of Dream Body Extreme Gold 800mg 30 gold capsules, Dream Body 450mg 30 white capsules, and Dream Body Advanced 400mg 30 purple capsules to the consumer level. The Dream Body Extreme 800mg Gold, Dream Body 450mg and Dream Body Advanced 400mg have been found to contain sibutramine after FDA sampling and testing.
Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. 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. This undeclared ingredient makes these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.
Dream Body Weight Loss has not received any reports of adverse events related to this recall to date.
The product is used as a dietary supplement and is packaged in clear packer jars and brown foil packets. The affected Dream Body 450mg, Dream Body Extreme Gold 800mg and Dream Body Advanced 400mg with UPC codes 6903023120128 were distributed Nationwide from January 2013 to June 16, 2016 to consumers via retail sales and internet transactions.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm509727.htm
In Hong Kong, the above products are not registered pharmaceutical products.
Ends/ Saturday, July 2, 2016
Issued at HKT 11:00
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