Magic Power Coffee reveals a recall
This article was originally published in The Tan Sheet
The distributors of Magic Power Coffee do not have a trick up their sleeve to make their product disappear from the market, but must rely on a recall. INZ Distributors Inc./Magic Power Coffee Inc. June 28 voluntarily recalled the dietary supplement in which FDA found hydroxythiohomosildenafil, an unapproved drug that is an analogue to sildenafil, the active ingredient in Pfizer's erectile dysfunction drug Viagra (1"The Tan Sheet" June. 28, 2010). The Brooklyn, N.Y., firm said no illnesses linked to the product have been reported. The recall covers production dates through May 8, 2010
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The distributor of a coffee product found to contain an analogue of the erectile dysfunction drug sildenafil receives an official FDA warning letter Aug. 23, following a consumer advisory and voluntary recall in June (1"The Tan Sheet" July 5, 2010, In Brief). INZ Distributors of Brooklyn, N.Y., sells an unapproved, misbranded new drug, the agency's New York District office says. Magic Power Coffee is an adulterated food, due to the presence of an ingredient not generally recognized as safe, and improperly labeled as a dietary supplement given its representation as a conventional food/beverage, FDA says. INZ faces product seizures and possible injunction if it fails to correct the violations within 15 days, according to the letter
FDA's consumer advisory against a coffee product that contains an active drug ingredient for erectile dysfunction reflects the agency's growing capability to keep up with noncompliant firms that add drug substances to so-called dietary supplements
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