Just days after consumers were urged to avoid Rock Hard Extreme and Passion Coffee Dietary Supplements, Drive Total Energy has announced it is recalling those products.
Word of the voluntary came after the company was informed by the Food and Drug Administration (FDA) that lab analyses found that the products to 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.
Possible dangers
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 our 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 said in a press release.
Consumer instructions
Rock Hard Extreme and Passion Coffee, distributed by Drive Total Energy, are sold on Internet sites, online marketplaces, and in retail outlets in single blister packs, single packets, and 10-count capsule bottles Rock Hard Extreme single pack Lot # 1152010, expiration date Jan. 15, 2013; Rock Hard Extreme Bottle Lot # 1152010, expiration date Jan. 15, 2013; Passion Coffee UPC 7 97882 00001 2.
The company advises consumers who have purchased these products to discontinue their use and return the products to their place of purchase for a full refund. Customers with questions can call Drive Total Energy at 1-619-825-9422 Pacific Coast Time Monday through Friday from 9:00 am – 5:00 pm PST for instructions on the return and refund process. Drive Total Energy says it did not in any way "knowingly or intentionally violate the law with regard to the distribution of these products."
Any adverse reactions or quality problems experienced with the use of these products may be reported to the FDA’s MedWatch Adverse Event Reporting program either online, by regular mail using use postage-paid, pre-addressed Form FDA 3500 and mail to the address on the pre-addressed form or by fax at 1-800-FDA-0178
