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Products found to contain undeclared medicines

 
The United States: The Body Shot Bar issues voluntary nationwide recall of Step 2 due to undeclared sibutramine
 
The U.S. Food and Drug Administration (FDA) announced that the Body Shot Bar is voluntarily recalling all lots distributed March 1- May 6 2016 of Step 2 60 gold capsule (350MG per) capsules to the consumer level. Step 2 has been found positive for Sibutramine after FDA sampling and testing. The product is used as a weight loss dietary supplement and is packaged in a white bottle in blue and gold. The affected Step 2 lots have expiration date 7/30/2017. Product was distributed nationwide to consumers via www.thebodyshotbar.com.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010. Sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias or stroke. The undeclared ingredient makes the product an unapproved new drug for which safety and efficacy have not been established. The product may also interact in life-threatening ways with other medications a consumer may be taking.

The Body Shot Bar has not received any complaints to date. The Body Shot Bar has not received any reports of adverse events related to this recall.

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm505374.htm

In Hong Kong, the above product is not a registered pharmaceutical product, and there is no registered pharmaceutical product manufactured by Body Shot Bar. Related news was previously issued by the FDA, and was posted on the Drug Office website on 7 May 2016.


Ends/ Wednesday, June 08, 2016
Issued at HKT 16:00
 
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