EphBurn 25 Dietary Supplement by Brand New Energy: Recall - Undeclared Drug Ingredient
ISSUE: Brand New Energy and FDA notified the public of a recall of all lot codes of EphBurn 25. One lot of EphBurn 25 sampled by the FDA was found to contain ephedrine alkaloids, making it an unapproved drug. This recall affects all lot codes and use by dates of EphBurn 25.
The ephedrine alkaloids work mainly by increasing the activity of noradrenaline on adrenergic receptors. A number of adverse effects associated with ephedrine alkaloid-containing dietary supplements have been reported to the FDA. These include elevated blood pressure, rapid heartbeat, nerve damage, muscle injury, and psychosis and memory loss. More serious effects have also been reported, including heart attack, stroke, seizure and death.
BACKGROUND: Ephedrine is commonly used as a stimulant, appetite suppressant, concentration aid, and decongestant, and it has been used to help aid in weight loss. EphBurn 25 is a 90-count bottle with red capsules and prominently displays the product name "ephBURN 25" in white letters on the front of a red label. There is no UPC code. EphBurn 25 was previously discontinued on or about May of 2012. EphBurn 25 was distributed to various retail stores nationwide, and the product was sold via the Internet from the period of time of approximately April 2010 through August 2012.
RECOMMENDATION: Consumers who may have purchased EphBurn 25 should immediately discontinue using the product and contact their health care professional if they have experienced any adverse effects.
[08/30/2012 - Press Release - Brand New Energy]