Deseo Rebajar Inc. Issues Voluntary Recall of Burn 7 Capsules Due to Undeclared Active Ingredient

Date of Recall

2013-12-24

Recall Details

- December 23, 2013 - 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 Sibutramine has been withdrawn from U.S marketplace.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 in our offices in Fajardo, Caguas and Bayamon and in website www.deseorebajar.com. We sincerely regret any inconvenience to our customers.

Consumers with questions should contact Deseo Rebajar Inc. at 787.961.6464 or via e-mail at [email protected] Monday - Friday, 8:00 am - 5:00 pm, [GMT time zone]. 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.

Adverse events that may be related to the use of this product may be reported to FDA's MedWatch Adverse Event Reporting program either 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. Mail to address on the pre-addressed form.
• Fax: 1-800-FDA-0178

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

Deseo Rebajar Inc. is taking this voluntary action because it is committed to the health and safety of its customers and to the quality of its select brands. We are working diligently to make available appropriate natural herbal regulations. We are moving forward with new custom formula. We value our relationship with you and will continue to provide you with the best

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