January 3, 2011
SAN DIEGODrive Total Energy announced a voluntary recall of its Rock Hard Extreme and Passion Coffee products, after FDA informed the company that lab testing found the products contained sulfoaildenafil, an analogue of sildenafil, which is an FDA-approved drug for treating male erectile dysfunction (ED). The presence of the drug, which is not listed on the product label, makes the products, sold as dietary supplements, adulterated and instead considered unapproved new drugs. The recall affects single blister packs, single packets and 10-count capsule bottles of 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.
Sulfoaildenafil may interact with some prescription drugs to lower blood pressure to dangerous levels. While Drive Total Energy said it has not received any consumer complaints and is not aware of any reports made to FDA concerning adverse effects from the use of the products, it urged consumers to discontinue the use of the affected items. Consumers and health care providers can report any adverse reactions to the products to FDAs MedWatch Adverse Event Reporting program online.
In its recall statement, the company noted it is committed to ensuring its products remain free of any unapproved chemicals, adding we did not in any way knowingly or intentionally violate the law with regard to the distribution of these products."
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