RegenArouse, a so-called dietary supplement, is being recalled for an undeclared drug ingredient, the U.S. Food and Drug Administration (FDA) just announced.
The recall has been implemented following an FDA analysis that confirmed the presence of Tadalafil, which makes these products unapproved new drugs, the FDA announced.
RegenArouse is produced by Regeneca Inc. and Lot Number 130100, is involved in the recall. RegenArouse, Lot Number 130100, is a pink capsule that is sold individually in foil packets. The expiration date is 12/5/2013 and the UPC is 816860010079.
Tadalafil, which is an FDA-approved drug used in the treatment of male erectile dysfunction (ED), is the active drug ingredient in RegenArouse, but is not listed on the label for these products.
The FDA warns that use of the recalled 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.
The agency has also noted that consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates. The FDA pointed out that ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
Regeneca, Inc. distributed RegenArouse via sales made over the Internet to consumers in the United States and Puerto Rico, between November 29, 2011 and February 10, 2012.
Regeneca, Inc. had this specific lot of RegenArouse capsules tested at a testing facility and received a report indicating that no PDE-5 inhibitors or any of their analogues were detected in the capsules. Regeneca learned that there was an error on this test..
Regeneca, Inc. advises that customers in possession of the recalled RegenArouse to return any unused product for an exchange, or a full refund, to the company directly. Regeneca Inc. can be reached, toll-free, at 1.800.690.6958, Monday through Friday, from 8:00 a.m. to 6:00 p.m., Pacific Time (PT) for instructions on the return and exchange and refund process.
Adverse reactions or quality problems experienced with the use of these recalled products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail or by fax: Online: http://www.fda.gov/MedWatch/report.htm; Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at: http://www.fda.gov/MedWatch/getforms.htm. Mail to address on the pre-addressed form; or Fax: 1-800-FDA-0178.