Undeclared Active Ingredient Leads to Burn 7 Supplement Recall
Deseo Rebejar Inc. has voluntarily recalled lot #MFD: 07.18.2013 (Exp. 7.17.2015) of Burn 7 Capsules at the consumer level. The product has been found to contain Sibutramine, an uapproved new drug that poses risks such as a substantial increase in blood pressure.
About the Recall
- The U.S Food and Drug Administration (FDA) conducted a laboratory analysis of the dietary supplement known as Burn 7 and found that the use of Sibutramine was unapproved.
- The ingredient was previously an approved controlled substance for for the treatment of obesity.
- The product was then removed from the U.S Market for safety reasons, making this product an unapproved new drug.
Details about the Sibutramine
- Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and a may present a significant risk to patients with a history of coronary artery disease, congestive failure, arrhythmias, or stroke.
- The active drug ingredient is not listed on the label or these products.
- The product was sold directly to individual customers in Deseo Rebajar Inc.'s offices in Fajardo, Caguas and Bayamon and at the website www.deseorebajar.com
- The company urges all consumers to contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this product.
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