UPDATE 1/3/2014. Spanish language Press Release added. See link below.
AUDIENCE: Consumer, Health Professional
ISSUE: 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 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.
BACKGROUND: 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.
RECOMMENDATION: 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. Consumers with questions should contact Deseo Rebajar Inc. at 787.961.6464 or via e-mail at email@example.com Monday - Friday, 8:00 am - 5:00 pm, [GMT time zone].
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch Safety Information and Adverse Event Reporting Program:
- Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
- Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178.
[Product Photos - FDA]