The agency posted on its website a statement by Drive Total Energy on the voluntary recall of Rock Hard Extreme and Passion Coffee, the products under a cloud now.
The products contain Sulfoaildenafil, an analogue of Sildenafil, an FDA-approved drug used in the treatment of male Erectile Dysfunction (ED), making these products unapproved new drugs. The active drug ingredient is not listed on the product label, the agency has 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.
To date, Drive Total Energy is not aware of any reports made to the FDA concerning any adverse effects associated with the use of Rock Hard Extreme or Passion Coffee. In addition, Drive Total Energy currently has not received any complaints from its customers, the firm claims. Still as a matter of abundant caution and concern for the health and welfare of our customers, the firm is voluntarily notifying its customers of the FDA’s findings, the statement from Drive Total Energy said.