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Products found to contain undeclared medicines

 
The United States: Bethel Nutritional Consulting, Inc. Expands Voluntary Recall to Include Bethel Advance and Quick Thin Products Found to Contain Undeclared Drug Ingredients Sibutramine and Phenolphthalein
 
The US Food and Drug Administration (FDA) announced that Bethel Nutritional Consulting, Inc., New York, NY, is voluntarily recalling Quick Thin and Bethel Advance to the consumer level. These products have been found to contain Sibutramine and Phenolphthalein. Bethel 30 green capsules were recalled by the firm on 11 June 2013 for the same reason.

Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The FDA has not approved Bethel 30, Quick Thin, and Bethel Advance as drugs; therefore the safety and effectiveness of these products are unknown. 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. These products may also interact, in life-threatening ways, with other medications a consumer may be taking. Phenolphthalein may present health risks that could include potentially serious gastrointestinal disturbances, irregular heartbeat, muscle cramps, and cancer with long term use. No illnesses or injuries have been reported to Bethel Nutritional Consulting to date in connection with these products.

Bethel 30 green capsules, Quick Thin gold capsules, and Bethel Advance white capsules are marketed as a natural herb for weight loss. The recalled products are packaged in plastic white bottles, 30 capsules per bottle as follows: Bethel 30 bears Lot # 120514 with exp. 12/05/2014 (recalled on 11 June 2013); Bethel Advance bears Lot # 10092011 with exp. 2014; Quick Thin bears Lot # 10032011 with exp. 10/2014. The products were sold directly to individual customers in our New York, NY, sales office and online at www.bethel30.com. The company has discontinued distribution and sales of these products. Consumers should not consume Bethel 30, Bethel Advance, and Quick Thin Herb Supplements and should return the products immediately to the place of purchase. 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/ucm363939.htm

In Hong Kong, the above products are not registered pharmaceutical products. Related news has been released by FDA and was posted on the website of Drug Office on 11 and 13 June 2013.


Ends/ Tuesday, August 06, 2013
Issued at HKT 12:00
 
Related Information:
The United States: Bethel Nutritional Consulting, Inc. issues a voluntary recall... Posted 2013-06-13
The United States: Public Notification: “Bethel 30” Contains Hidden Drug Ingredi... Posted 2013-06-11
 
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