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Products found to contain undeclared medicines

 
The United States: Herbal Give Care LLC Issues Voluntary Nationwide Recall of Esbelder Man Capsules, Esbelder Fem Capsules, and Esbelder Siloutte Capsules Vitamin Supplements Due to Potential Health Risks
 
The US Food and Drug Administration (FDA) announced that Herbal Give Care LLC is voluntarily recalling all lots of Esbelder man (30 capsules), Esbelder fem (30 capsules) and Esbelder siloutte (30 capsules) to the consumer level. The products have been found to contain undeclared Sibutramine, N-Desmethylsibutramine, and N-di-Desmethylsibutramine. The presence of these undeclared ingredients makes these products unapproved drugs. These products may 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. To date, Herbal Give Care LLC has not received any reports of adverse events related to this recall. The products were distributed Nationwide to retail customers and via the internet. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using these drug products.

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm365487.htm

In Hong Kong, the above products are not registered pharmaceutical products.


Ends/ Tuesday, August 20, 2013
Issued at HKT 12:00

 
 
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