Rock Hard Extreme and Passion Coffee by Drive Total Energy: Recall - Undeclared Drug Ingredient
ISSUE: FDA notified consumers that lab analyses found that Rock Hard Extreme and Passion Coffee products contained 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. Use of these products may pose a threat to consumers because the analogue 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. ED is a common problem in men with these conditions, and consumers may seek these types of products to enhance sexual performance.
BACKGROUND: 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.
RECOMMENDATION: Consumers who have purchased these products should discontinue their use and return the products to their place of purchase for a full refund.
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