Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, And Casanova: Recall - Undeclared Ingredients Sulfoaildenafil and Thioaildenafil
ISSUE: Performance Plus Marketing, Inc. Issues a Voluntary Nationwide Recall of Libigrow, Libigrow XXXtreme, Blue Diamond, Blue Diamond Platinum, Mojo Nights, Mojo Nights Supreme, and Casanova because they contain undeclared Sulfoaildenafil and Thioaildenafil. Sulfoaildenafil and thioaildenafil are close in structure to sildenafil and are expected to possess a similar pharmacological and adverse event profile. This poses a threat to consumers because sildenafil 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.
BACKGROUND: These products are marketed as a dietary supplement sexual enhancer for men. The product was sold to distributors and retail stores nationwide and via internet sales.
RECOMMENDATION: Consumers should not consume these products return them immediately to the place of purchase for a full refund. Consumers should contact their physician if they have experienced any problems that may be related to taking these products.
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
[12/14/2012 - Press Release - Performance Plus Marketing, Inc.]