Products Recalled Due to Undeclared Sildenafil Analogues
This is a reprint of an FDA Alert.
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
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 tested 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. See list of affected lot numbers at the bottom.
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.
•Online: http://www.fda.gov/MedWatch/report.htm.
•Regular mail: use postage-paid, pre-addressed Form FDA3500 available at http://www.fda.gov/MedWatch/getforms.htm.
•Fax: 1-800-FDA-0178
This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
Note: This is the second recall this year conducted on a product of this name. A previous voluntary recall was conducted in September for Evol Nutrition Associates’ product also called Mojo Nights and Mojo Nights For Her.
Affected lots:
|
Product |
UPC Code |
Packaging Type | Number of Capsules | Lot Numbers | Expiration Date |
|
Libigrow® |
094922567611 |
1-count blister |
1 |
*791115 |
12/13 |
|
|
*01M0111 |
01/14 |
|||
|
*01M0212-1 |
02/15 |
||||
|
*01M0212 |
02/15 |
||||
|
*01M0611-2 |
06/14 |
||||
|
|
094922567628 |
5-count blister |
5 |
05M0412 |
04/16 |
|
|
610585434253 |
10-count blister |
10 |
10M0412 |
04/16 |
|
Libirgow XXX® |
705105830735 |
1-count blister |
1 |
*01MNU0912 |
09/15 |
|
|
|
|
|
*01X0412-1 |
04/15 |
|
|
|
|
|
*021647 |
12/13 |
|
|
610585435939 |
5-count blister |
5 |
05X0412 |
04/16 |
|
|
610585435922 |
10-count blister |
10 |
10X0412 |
04/16 |
|
|
|
10-count blister |
10 |
10M0111 |
01/14 |
|
Blue Diamond® |
705105524764 |
1-count blister |
1 |
*01M0412 |
04/15 |
|
|
1 |
*91782 |
01/14 |
||
|
|
736211124012 |
5-count blister |
5 |
05M0412 |
04/15 |
|
|
736211123916 |
10-count blister |
10 |
10M0412 |
04/15 |
|
Blue Diamond Platinum® |
608641933543 |
1-count blister |
1 |
01MNU0912 |
08/15 |
|
|
608641932867 |
5-count blister |
5 |
05BD0712 |
07/15 |
|
|
121781 |
01/14 |
|||
|
|
608641933536 |
10-count blister |
10 |
05BD0712 |
07/15 |
|
Mojo Nights® |
718122119738 |
1-count blister |
1 |
*01MJ0712 |
07/15 |
|
|
718122119738 |
1-count blister |
1 |
*01MM0211 |
07/15 |
|
|
705105836430 |
5-count blister |
5 |
05M0912 |
10/15 |
|
Mojo Nights Supreme® |
610585435915 |
1-count blister |
1 |
01MJS0712 |
07/15 |
|
Casanova® |
736211906892 |
1-count blister |
1 |
*030112 |
03/15 |