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Products found to contain undeclared medicines

 
The United States: New Life Nutritional Center Issues Voluntary Nationwide Recall of Super Fat Burner, Maxi Gold and Esmeralda Dietary Supplements Due to the Presence of Undeclared Sibutramine and Phenolphthalein
 
The US Food and Drug Administration (FDA) announced that New Life Nutritional Center is recalling all lots of “Super Fat Burner capsules, Maxi Gold capsules and Esmeralda softgels” to the user level after FDA analysis revealed the products contain undeclared active pharmaceutical ingredients: sibutramine, phenolphthalein or a combination of both sibutramine and phenolphthalein.

Sibutramine is an appetite suppressant that was withdrawn from the US market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes). 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 US. These undeclared ingredients make these products unapproved new drugs for which safety and efficacy have not been established. At this time no illnesses or injuries had been reported to New Life Nutritional Center in connection with these products.

These products are used as weight loss aids and are packaged in 30 capsule bottles. All lots of these products are being recalled. New Life Nutritional Center distributed these products to customers residing in NY, NJ, LA, TX, VA, and MA via retail stores and internet sales through their website at www.newlifenutritional.com. Customers are advised to immediately discontinue use of these products and should return the products immediately to New Life Nutritional Center.

Please refer to the following website in FDA for details: http://www.fda.gov/Safety/Recalls/ucm390608.htm

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


Ends/ Wednesday, March 26, 2014
Issued at HKT 13:00
 
Related Information:
Canada: Foreign Product Alerts: Super Fat Burner capsules, Maxi Gold capsules an... Posted 2014-07-17
 
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