FDA Issues Recall For Male Enhancement Drug Marketed As Supplement
March 13, 2012
The Food and Drug Administration (FDA) recently required Regeneca, Inc., to recall single capsule packets of the product RegenErect, which was being marketed as a dietary supplement, because it contained the drug Tadalafil. The press release for the recall issued by the FDA stated that Tadalafil is used in the treatment of male erectile dysfunction.
The FDA says that the drug, which is considered the active ingredient in the capsule, was not listed on the packaging. The other problem is that including the ingredient qualifies the product as a new drug, and it must therefore be approved by the agency before it can be sold.
The products could be considered dangerous for patients who are also taking nitrates and could possibly lower their blood pressure to dangerous levels. The FDA has stated that men suffering from diabetes, high blood pressure, high cholesterol, or heart disease who take nitrates may be at a particularly high risk of complications.
The company has asked that consumers with any unused product contact them directly to receive an exchange or full refund. Customers can call (800) 690-6958 Monday through Friday from 8 a.m. until 6 p.m. for instructions on obtaining a refund.
Any adverse reactions to the product should be reported to the FDA immediately.