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Products found to contain undeclared medicines

 
The United States: Lucy's Weight Loss System issues voluntary nationwide recall of Pink Bikini and Shorts on The Beach due to undeclared sibutramine and phenolphthalein
 
Lucy's Weight Loss System is voluntarily recalling all lots distributed May 25 - June 23 2015 of Pink Bikini and Shorts on the Beach Blue and Gold Edition, 30 blue capsules (750MG per) capsules and 30 gold capsules (800MG per) capsules to the consumer level. The Pink Bikini and Shorts on the Beach have been found positive for Sibutramine and Phenolphthalein after FDA sampling and testing.

Sibutramine is an appetite suppressant that was withdrawn from the U.S. market in October 2010.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. Health risks associated with phenolphthalein could include potentially serious gastrointestinal disturbances, irregular heartbeat, and cancer with long-term use. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. These products may also interact in life-threatening ways with other medications a consumer may be taking.

Lucy's Weight Loss System has not received any complaints and any reports of adverse events related to this recall.

The product is used as a weight loss dietary supplement and is packaged in clear bottle in blue and gold. The affected Pink Bikini and Shorts on the Beach lots include the expiration date 7/30/2017. Product was distributed nationwide to consumers via Internet. 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/ucm464076.htm

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


Ends/ Thursday, September 24, 2015
Issued at HKT 13:00
 
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