SexVoltz, Velextra, and Amerect by Beomonstar Products: Recall - Undeclared Drug Ingredient

UPDATED 05/13/2013. Recall expanded to include SexVoltz 12 Capsules bottle, SKU 626570615316.

[Posted 05/08/2013]

AUDIENCE: Consumer

ISSUE: BeaMonstar Products notified the public that it is recalling its SexVoltz, Velextra, and Amerect capsules to the retail level. Laboratory analysis conducted by the FDA on SexVoltz and Velextra has determined these products contain undeclared tadalafil. Amerect is voluntarily recalled because it has the potential to contain undeclared tadalafil. Tadalafil is an FDA-Approved drug used to treat male erectile dysfunction (ED), making the products unapproved new drugs.

This undeclared active ingredient poses a threat to consumers because tadalafil 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.

SexVoltz SKU’s 626570609490, 827912089028, 626570617877, 626570615316
Velextra SKU’s 626570619475, 626570619475, 626570619475, 626570619475
Amerect SKU’s 626570619031, 626570619598

The affected ‘Maximum Strength’ SexVoltz, Velextra, and Amerect are all lots distributed and sold from January of 2012 to May 7, 2013 and contain various expiration dates.

BACKGROUND: The product is used as a sexual enhancement product and all 3 products are packaged in blister type packaging in 1 & 2 caps, and in 4 capsule and 10 capsule bottles.  SexVoltz, Velextra, and Amerect was distributed Nationwide to wholesalers, retail, and via the internet.

RECOMMENDATION: BeaMonstar Products is notifying its distributors and customers by email and telephone and is arranging for credit of all recalled products. Consumers/distributors/retailers that have Sexvoltz, Velextra or Amerect which is being recalled should return to place of purchase.

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 Safety Information and Adverse Event Reporting Program:

• Complete and submit the report Online: www.fda.gov/MedWatch/report.htm
• Download form or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178

[05/10/2013 - Firm Press Release - BeaMonstar Products]
[05/07/2013 - Firm Press Release - BeaMonstar Products]
[05/07/2013 - Product Photos]