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Recall -- Firm Press Release

 

FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.

 

Recall - Performance Plus Marketing Press Release

 

Contact:
Consumer:
800-625-8806
 

FOR IMMEDIATE RELEASE - December 17, 2012 - 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.

Performance Plus Marketing, Inc. has been informed by the US Food and Drug Administration (FDA) that FDA lab analysis of Mojo Nights® distributed by the company was found to contain undeclared sulfoaildenafil and thioaidenafil, which are analogues of sildenafil. Counterfeit of Libigrow® brands have also test positive for sildenafil and other analogues thereof. Sildenafil is an FDA-approved drug for the treatment of male Erectile Dysfunction (ED), making Libigrow®, Libigrow XXXtreme®, Blue Diamond®, Blue Diamond Platinum®, Mojo Nights®, Mojo Nights Supreme®, and Casanova® unapproved drugs.

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.

Recall includes ALL authentic Lot numbers and *known to be counterfeit lot numbers of authentic lots. Any packaging types that are different from listed are counterfeit. Any lot numbers not listed are counterfeit and are also part of the recall.

 

ProductUPC CodePackaging TypeNumber of CapsulesLot NumbersExpiration Date
Libigrow®0949225676111-count blister1*79111512/13
 *01M011101/14
*01M0212-102/15
*01M021202/15
*01M0611-206/14
 0949225676285-count blister505M041204/16
 61058543425310-count blister1010M041204/16
Libirgow XXX®7051058307351-count blister1*01MNU091209/15
    *01X0412-1
 
04/15
 
    *02164712/13
 610585435939
 
5-count blister
 
5
 
05X0412
 
04/16
 
 610585435922
 
10-count blister
 
10
 
10X0412
 
04/16
 
  10-count blister1010M011101/14
Blue Diamond®7051055247641-count blister1*01M041204/15
 1*9178201/14
 7362111240125-count blister505M041204/15
 73621112391610-count blister1010M041204/15
Blue Diamond Platinum®6086419335431-count blister101MNU091208/15
 6086419328675-count blister505BD071207/15
 12178101/14
 60864193353610-count blister1005BD071207/15
Mojo Nights®7181221197381-count blister1*01MJ071207/15
 7181221197381-count blister1*01MM021107/15
 7051058364305-count blister505M091210/15
Mojo Nights Supreme®610585435915
 
1-count blister
 
1
 
01MJS0712
 
07/15
 
Casanova®7362119068921-count blister1*03011203/15

 

Libigrow®, Libigrow XXXtreme®, Blue Diamond®, Blue Diamond Platinum®, Mojo Nights®, Mojo Nights Supreme®, and Casanova® are marketed as a dietary supplement sexual enhancer for men. The product was sold to distributors and retail stores nationwide and via internet sales.

No illnesses or injuries have been reported to the company to date in connection with this product.

Performance Plus Marketing, Inc., a California Corporation, is committed to providing accurate information about its products because of concerns for the health and safety of consumers. Performance Plus Marketing, Inc. is working voluntarily with the FDA in the recall process. It sincerely regrets any inconvenience to customers. The company has discontinued distribution of these affected products until further notice.

Consumers should not consume Libigrow®, Libigrow XXXtreme®, Blue Diamond®, Blue Diamond Platinum®, Mojo Nights®, Mojo Nights Supreme®, and Cassanova® should return it 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. Consumers with questions should contact the recall coordinator at 800-625-8806, Monday through Friday, 9:00 am to 5:30 pm, PST.

Consumers and health care professionals should report adverse events that may be related to the use of this product to the U.S. Food and Drug Administration's (FDA) MedWatch Adverse Events Program either online, by regular mail or by fax.

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

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