Drive Total Energy is conducting the recall after lab analyses found that the products contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED).
The existence of the ingredient in the products makes them unapproved new drugs. The active drug ingredient is not listed on the product label.
Risk to customer
The company said the undeclared ingredient may pose a threat to the consumer because the interaction of the analogue with some prescription drugs (such as nitroglycerin) may lower blood pressure to dangerous levels.
“Consumers with diabetes, high blood pressure, high cholesterol, or heart disease often take other prescription drugs. Erectile Dysfunction is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance,” said Drive Total Energy.
The company said that to date, it is not aware of any reports made to the FDA concerning any adverse effects associated with the use of Passion Coffee or Rock Hard Extreme.
“It is the position Drive Total Energy that we did not in any way knowingly or intentionally violate the law with regard to the distribution of these products,” said the company.
In addition, Drive Total Energy said it has currently not received any complaints from its customers.
“Out of an abundance of caution and concern for the health and welfare of our customers, Drive Total Energy is voluntarily notifying our customers of the FDA’s findings,” the company added.