Burn 7 Dietary Supplement Recall [US]


US FDA RecallUS/Silver Spring: Deseo Rebajar recalls some Burn 7 Dietary Supplements due to undeclared Sibutramine, a drug that was removed from the market for safety reasons. FDA: http://ht.ly/s366TBurn 7 Dietary Supplement

Direct link: http://www.fda.gov/Safety/Recalls/ucm379811.htm

Additional information:
The US Food and Drug Administration (“FDA”) reports the following Foods are subject to this recall:

  • Burn 7 Capsules, lot #MFD: 07.18.2013, expiry: 07.17.2015

According to the FDA, laboratory analysis of this Dietary Supplement 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 US market in October 2010 for safety reasons, making the recalled product an unapproved new drug.

About Sibutramine:
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 Sibutramine has been withdrawn from US marketplace.

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Recalls Direct RIN: 2013-2894
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E. & O. E.

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