Products found to contain undeclared medicines
|
| |
| The United States: Ultimate Body-Tox issues a nationwide voluntary recall of Ultimate Body Tox PRO – product found to contain undeclared sibutramine |
| |
High Point, NC, Ultimate Body-Tox is voluntarily recalling all lots of Ultimate Body Tox PRO capsules to the consumer level. FDA analyses of this product found it to contain undeclared sibutramine. Sibutramine is a controlled substance that was removed from the U.S. market in October 2010 for safety reasons. The presence of sibutramine in Ultimate Body Tox PRO renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall. No illnesses or injuries have been reported to Ultimate Body-Tox to date in connection with this product. This recall does not affect the sales and distribution of Ultimate Body-Tox’s other products.
Ultimate Body Tox PRO is marketed as a dietary supplement for weight loss and is packaged in 45 count bottles. All lots are included in this recall. The products were sold and distributed nationwide via the internet and in NC.
The product poses 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, irregular heartbeat, or stroke.
Consumers, distributors, and retailers that have Ultimate Body Tox PRO should stop using and/or distributing the product, and return to place of purchase.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm531190.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Thursday, December 01, 2016
Issued at HKT 13:00
|
| |
