Products found to contain undeclared medicines
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| The United States: Bethel Nutritional Consulting, Inc. Issues Nationwide Voluntary Recall of SLIM-K Capsules Due to Undeclared Drug Ingredients Sibutramine, Desmethylsibutramine, and Phenolphthalein |
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The US Food and Drug Administration (FDA) announced that Bethel Nutritional Consulting, Inc. is recalling one lot of SLIM-K Capsules to the consumer level (Lot # 140430). The firm was informed by FDA that a sample of SLIM-K collected and tested by the FDA was found to contain sibutramine, desmethylsibutramine, 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Sibutramine is an appetite suppressant that was withdrawn from the US market in October 2010 (due to increased risk of seizures, heart attacks, arrhythmia and strokes).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 this product an unapproved new drug for which safety and efficacy have not been established.
No illnesses or injuries have been reported to the company to date in connection with this product. SLIM-K Capsules are marketed as a Natural Herbal Supplement for Weight Loss. The product was sold directly to individual customers in New York City office and online to consumers at www.bethel30.com. The company has discontinued distribution of this product.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm427662.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/ Monday, December 22, 2014
Issued at HKT 13:00
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