Products found to contain undeclared medicines
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| The United States: Fit Firm and Fabulous issues voluntary nationwide recall of Ultimate Herbal Slimcaps due to the presence of undeclared sibutramine |
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Fit Firm and Fabulous is voluntarily recalling lots 05/02/2015 to 05/01/2017 of Ultimate Herbal Slimcap capsules, to the consumer level. FDA analysis has found the product to contain undeclared sibutramine. Sibutramine was a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons. This ingredient makes Ultimate Herbal Slimcap an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
Products containing sibutramine pose a threat to consumers because 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. These products may also interact in life threatening ways with other medications a consumer may be taking. To date, Fit Firm and Fabulous has not received any reports of adverse events related to this recall.
The product is a dietary supplement marketed for weight loss and is packaged in 30-count bottles, labeled Part 1 of 3, UPC 5 42423 25422 1. The affected Ultimate Herbal Slimcap lots include the following lots 05/02/2015 to 05/01/2017. Ultimate Herbal Slimcaps was distributed Nationwide via the website.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm473638.htm
In Hong Kong, the above product is not a registered pharmaceutical product. Related news has been issued by the US FDA, and was posted on the Drug Office website on 2 October 2015.
Ends/ Friday, November 20, 2015
Issued at HKT 16:30
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