Regeneca (PK: RGNA) Recalls RegenArouse Due to Possible Health Risk

Tallahassee, FL 2/13/12 (StreetBeat)-- Wellness product maker Regenca, Inc. (Pink Sheets:RGNA) reported on Saturday that it is conducting a voluntary nationwide recall of Lot Number 130100 of RegenArouse because Food and Drug Administration (FDA) lab analysis has confirmed the presence of Tadalafil (Brand names: Adcirca, Cialis) making these products unapproved new drugs. Tadalafil is an FDA-approved drug for Erectile Dysfunction, but the active drug ingredient is not listed on the label for the RegenArouse product.

Sold online to consumers in the States and Puerto Rico between November 29, 2011 and February 10, 2012, Lot Number 130100 of RegenArouse is a pink capsule sold individually in foil packets, with the expiration date of 12/5/2013 and a UPC code of 816860010079. Customers are advised to return their product with matching lot number and UPC code for an exchange or full refund. Any adverse reactions should be reported to FDA’s MedWatch Adverse Event Reporting program (http://www.fda.gov/MedWatch/report.htm).

According to the company, the specific batch had been tested previously and no PDE-5 inhibitors were detected, but then learned that there was an error in the testing, so they are conducting the recall. The company is currently improving their testing procedures.

Use of these products 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. Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates and Erectile Dysfunction is a common problem in men with these conditions; resulting in the potential interaction of the drugs.

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