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Nature & Health Co. announces voluntary, natiowide recall

4/30/2009

BREA, Calif. Nature & Health Co. on Tuesday announced that it is conducting a voluntary nationwide recall of the company's supplement product sold under the name Libimax after being informed by representatives of the Food and Drug Administration that Libimax samples could contain tadalafil, the active ingredient in Lilly’s prescription-only erectile dysfunction drug Cialis.

The product is distributed through vitamin stores, grocery stores and liquor stores, according to the company’s Web site.

FDA advised that this poses a threat to consumers because tadalafil may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. According to the FDA, consumers with diabetes, high blood pressure, high cholesterol or heart disease often take nitrates.

FDA advises that ED is a common problem in men with these conditions, and they may seek products to enhance sexual performance. FDA advises that tadalafil, may cause side effects, such as headaches and flushing.

The recalled Libimax is sold as a 1 capsule individual pack or 10-capsule and 20-capsule plastic bottles in retail stores in California, Georgia, Illinois, Texas and Ohio.  The product label neither states it contains tadalafil nor warns consumers with high blood pressure not to ingest the product.

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