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Products found to contain undeclared medicines

 
The United States: SmartLipo365 issues voluntary nationwide recall of Smart Lipo due to undeclared sibutramine, desmethylsibutramine, and phenolphthalein
 
SmartLipo365 is voluntarily recalling 122 lots of Smart Lipo (800, 900, 950 mg) capsules, to the consumer level. FDA received samples of 800 and 900mg capsules of Smart Lipo and the lab results found the Smart Lipo products to contain undeclared sibutramine, desmethylsibutramine, and phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.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. Phenolphthalein is an ingredient previously used in over-the-counter laxatives, but because of concerns of carcinogenicity, it is not currently approved for marketing in the United States.

Smart Lipo is marketed as a dietary supplement and is packaged in bottles of 30 capsules, with 22 bottles of 800mg, 77 bottles of 900mg, and 23 bottles of 950mg. The affected Smart Lipo products include the following expiration dates: 800mg capsules - 9/15/2017, 900mg capsules - 7/30/2017, 950mg capsules - 7/30/2017 & 7/30/2018. Smart Lipo was sold in stores, Centro Naturista in Richardson, TX, SmartLipo365 in Arlington, TX, as well as distributed nationwide via the Internet, SmartLipo365.com.

SmartLipo365 is notifying its distributors and customers by e-mail and letter and will not continue the distribution of Smart Lipo. Consumers, distributors, retailers that have Smart Lipo which is being recalled should stop using the recalled product and asked to please dispose it. 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.

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm449741.htm

In Hong Kong, the above product is not a registered pharmaceutical product.


Ends/ Friday, June 05, 2015
Issued at HKT 15:00
 
 
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