Undisclosed Ingredients Make Local Dietary Supplement Manufacturer Recall Female Sexual Enhancers

Following a confirmed analysis by the U.S. Food and Drug Administration (FDA), a Southern California dietary supplement manufacturer is in the process of recalling products that tested positive for undisclosed ingredients. Regeneca, Inc., operating out of Irvine, announced this weekend that they are recalling specific lots of RegenArouse after FDA testing revealed traces of tadalafil. The active drug ingredient is not listed on the label for these products and may be harmful to particular populations.

RegenArouse was developed with the intentions of enhancing and supporting the sexual experience for women. However, an FDA lab analysis confirmed the presence of Tadalafil, making these products unapproved new drugs. Tadalafil is an FDA-approved drug used as treatment for male Erectile Dysfunction (ED). According to a recent FDA Safety Announcement, tadalafil may cause severe, life-threatening complications if used in the wrong circumstances.

The FDA has advised that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates to control their situation. Subsequently, the FDA has also acknowledged that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance. However, the use of products containing tadalafil may pose a threat to consumers. Studies suggests that the introduction of tadalafil to nitrates may result in adverse health events. The adverse reaction tadalafil exhibits with nitrates may lower blood pressure to dangerous levels.

Due to the dangerous rise in blood pressure associated with tadalafil use, Regeneca, Inc. announced this weekend that it is conducting a voluntary nationwide recall of RegenArouse, Lot Number 130100. RegenArouse, Lot Number 130100, is a pink capsule sold individually in foil packets, with the expiration date of 12/5/2013 and a UPC code of 816860010079. Regeneca, Inc. had this specific lot of RegenArouse capsules tested at a testing facility and had received a report indicating that no PDE-5 inhibitors or any of their analogues were detected in the capsules. The dietary supplement company recently learned that there was an error on this test and has thus made the decision to issue a voluntary nationwide recall on this lot of RegenArouse.

Regeneca, Inc. has distributed RegenArouse via sales made over the internet to consumers in the United States of America and Puerto Rico between November 29, 2011 and February 10, 2012.

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