Products found to contain undeclared medicines
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| The United States: Burn 7 Capsules by Deseo Rebajar: Recall - Undeclared Drug Ingredient Sibutramine |
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The US Food and Drug Administration (FDA) announced that Deseo Rebajar Inc., is voluntarily recalling lot #MFD: 07.18.2013 (Exp: 07.17.2015) of Burn 7 Capsules to the consumer level. FDA laboratory analysis found the Burn 7 Capsules to contain undeclared Sibutramine.
Sibutramine was a previously approved controlled substance for the treatment of obesity that was removed from the US market in October 2010 for safety reasons, making this product an unapproved new drug. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk to patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke.
The recalled products are packaged in 30-count plastic bottles labeled with lot number #MFD: 07.18.2013. The product lot was sold directly to individual customers in Fajardo, Caguas and Bayamon, Puerto Rico, and in website www.deseorebajar.com. 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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/MedWatch/../ucm379831.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Friday, December 27, 2013
Issued at HKT 12:00
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