Weight-loss, male enhancement drugs recalled
This article was originally published in The Tan Sheet
Executive Summary
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)
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FDA warns about sexual enhancement supplement
The agency warns consumers Aug. 25 about TimeOut Capsules because they contain an undeclared ingredient. Hydroxythiohomosildenafil is similar to sildenafil, the FDA-approved ingredient in Pfizer's prescription Viagra, and may interact with nitrates to cause unsafe drops in blood pressure. "TimeOut is labeled as '100% natural' and consumers may mistakenly assume the product is harmless and poses no health risk," FDA said. The TimeOut warning is the latest in what has become a stready stream of alerts and recall announcements for so-called weight-loss and male enhancement supplements found to contain undeclared drugs (1"The Tan Sheet" Aug. 23, 2010, In Brief)
FDA issues adulterated supplement warnings
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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