December 24, 2013
Deseo Rebajar Inc. Issues Voluntary Recall of Burn 7 Capsules Due to Undeclared Active Ingredient
The Missouri Department of Health and Senior Services was informed that Deseo Rebajar Inc., is voluntarily recalling lot #MFD: 07.18.2013 (Exp: 07.17.2015) of Burn 7 Capsules to the consumer level. The FDA laboratory analysis of this dietary supplement found the Burn 7 Capsules product 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. 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. Sibutramine has been withdrawn from U.S marketplace. The active drug ingredient is not listed on the label for these products. 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 through offices in Fajardo, Caguas and Bayamon and on the website www.deseorebajar.com.
The full recall can be found at: http://www.fda.gov/Safety/Recalls/ucm379811.htm?source=govdelivery&utm_medium=email&utm_source=govdelivery.