A recall has been issued for EphBurn 25 supplements, the U.S. Food & Drug Administration (FDA) just announced. Brand New Energy, a dietary supplement re-sale distributor, is recalling all lot codes of EphBurn 25.
The recall was implemented on August 28, 2012 after the FDA notified a third-party retailer, which purchased EphBurn 25, that one lot of EphBurn 25 was sampled by the FDA and found to contain ephedrine alkaloids, which makes the supplement an unapproved drug.
Ephedrine is typically used as a stimulant, appetite suppressant, concentration aid, and decongestant. Ephedrine has also been used to help in weight loss. Ephedrine alkaloids work by increasing the noradrenaline activity on adrenergic receptors.
Adverse effects associated with ephedrine alkaloid-containing dietary supplements reported to the FDA include elevated blood pressure, rapid heartbeat, nerve damage, muscle injury, psychosis and memory loss, heart attack, stroke, seizure, and death. To date, no reports of adverse events have been linked to the recalled EphBurn 25 supplements.
The recalled EphBurn 25 are red capsules packaged in a 90-count bottle that prominently displays the product name “ephBURN 25″ in white letters on the front of a red label. There is no UPC. EphBurn 25 was previously discontinued on or about May 2012. The recalled EphBurn 25 was distributed to various retail stores, nationwide, and was sold via the Internet from April 2010 through August 2012.
The firm advises consumers to immediately discontinue using the recalled EphBurn 25 and contact their health care professional if they have experienced any adverse effects. Consumers can contact the distributor of the product at firstname.lastname@example.org or, toll-free, at 1.888.234.2595, from 8:00 a.m. to 4:00 p.m., Pacific Standard Time (PST) with questions and to receive instructions for returning the product.
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax: Online: www.fda.gov/medwatch/report.htm; regular mail, use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm and mail to the address on the pre-addressed form or fax to 1.800.FDA.0178.