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An herbal pill sold as a "natural intimacy enhancement" for females has been recalled because of the undeclared presence of tadalafil (Cialis, Eli Lilly), a drug used as a treatment for male erectile dysfunction, FDA announced.
An herbal pill sold as a “natural intimacy enhancement” for females has been recalled because of the undeclared presence of tadalafil (Cialis, Eli Lilly), a drug used as a treatment for male erectile dysfunction (ED), FDA announced.
A single lot of RegenArouse, number 130100, was recalled, according to Regeneca, which makes the product.
FDA warned that use of RegenArouse may pose a threat to consumers because it may interact with nitrates found in some prescription drugs (such as nitroglycerin) and may lower blood pressure to dangerous levels. FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance, FDA said in a news release.
RegenArouse is a pink capsule sold through the internet in individual foil packets. The recalled lot has an expiration date of 12/5/2013 and a UPC code of 816860010079.
Regeneca said customers with the RegenArouse product matching the lot number should return any unused product for an exchange, or a full refund, to the company.
Healthcare professionals and patients are encouraged to report adverse events or side effects related to the use of these products to the FDA's MedWatch website.