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FDA issues adulterated supplement warnings

This article was originally published in The Tan Sheet

Executive Summary

FDA warns consumers to stop taking Slim-30 Herb Supplement, a weight- loss supplement that contains undeclared sibutramine. Sibutramine is an FDA-approved product, but the agency has not approved Slim-30 Herb Supplements, so its safety in the product is unknown. Sibutramine may present a "significant risk" to patients with congestive heart failure, stroke or other cardiac conditions, FDA says. The agency also warns consumers not to take Joyful Slim Herb Supplement, marketed by J&H Besta Corp., because it contains undeclared desmethyl sibutramine. The company announced July 22 a recall of product lot 101408 including 30-count bottles with the UPC 897966002007. In addition, Good Health Inc. recalls Vialipro, a product marketed as a supplement for sexual enhancement. The firm said July 16 that FDA found sulfoaildenafil, an analogue of the pharmaceutical ingredient sildenafil, in certain batches. FDA previously warned of criminal charges for undeclared pharmaceuticals in OTC drugs, and has issued warnings leading to recalls of tainted supplements

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Slimming Beauty warning

FDA warns consumers not to take Slimming Beauty Bitter Orange Slimming Capsules because they contain undeclared sibutramine. The prescription weight-loss ingredient is particularly dangerous to people with heart conditions. Abbott Laboratories announced Oct. 8 it is taking prescription sibutramine (Meridia) off the market. Slimming Beauty is made by Beautiful Health, Inc. and was sold online and distributed at community events, FDA has issued multiple warnings about tainted supplements (1"The Tan Sheet" July 26, 2010, In Brief)

Weight-loss, male enhancement drugs recalled

The maker of Mr. Magic Male Enhancer from Don Wands sexual enhancement product voluntarily launches a recall after FDA determined the presence of undeclared ingredients. Glow Industries said Aug. 18 it recalled Mr. Magic because it contains hydroxythiohomosildenafil and sulfoaildenafil, analogues of sildenafil, an Rx ingredient for treatment of erectile dysfunction that may react unsafely with nitrates. Separately on Aug. 19, J&H Besta expanded a previous recall of its Slim-30 Herb Supplement weight-loss product, the subject of a recent FDA consumer advisory, because it contains undeclared desmethyl sibutramine, similar in structure to the appetite suppressant drug sibutramine (1"The Tan Sheet" July 26, 2010, In Brief)

More Top-Level Pharma Changes In India, Cipla Gets CSO

Top-level personnel movement continues at pharma firms in India, with Cipla now appointing an ex-Amneal executive as its Chief Scientific Officer, while Abbott has effected a rejig at the helm.





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