Making It A Lifestyle, L.L.C. Supplements 3rd Degree, Black Gold X Advanced, and Black Label X: Recall - Undeclared Drug Ingredients

[Posted 05/02/2016]

AUDIENCE: Consumer

ISSUE: Making It A Lifestyle, L.L.C. is voluntarily recalling all lots of 3rd Degree, Black Gold X Advanced and Black Label X capsule form supplements to the consumer level. The products have been found to contain undeclared sibutramine and sildenafil. These undeclared ingredients make these products an unapproved new drug for which safety and efficacy have not been established.

FDA laboratory analysis confirmed that 3rd Degree and Black Gold X Advanced contains sibutramine. Sibutramine is a controlled substance that was removed from the market in October 2010 for safety reasons. The product poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients and may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. This product may also interact, in life-threatening ways, with other medications a consumer may be taking. Additionally, FDA laboratory analysis confirmed that Black Label X contains sildenafil, the active ingredient in the FDA approved prescription drug Viagra, used to treat erectile dysfunction (ED). This undeclared ingredient may interact with nitrates found in some prescription drugs such as nitroglycerin and may lower blood pressure to dangerous levels. Men with diabetes, high blood pressure, high cholesterol, or heart disease often take nitrates.

BACKGROUND: Black Label X, Black Gold X Advanced, and 3rd Degree are marketed as weight loss dietary supplements and are packaged in white plastic bottles, containing 60 capsules per bottle. The products can be identified by the names on the bottle. These products were distributed nationwide via internet. The recalled products were distributed from February 2015 to April 27th 2016.

RECOMMENDATION: Making It A Lifestyle, L.L.C. is notifying its distributors and customers by e-mail and is arranging for return of all recalled products. Consumers who have the recalled products should stop using them.

Consumers with questions regarding this recall can contact Making It A Lifestyle, L.L.C. via by phone 1-888-648-4447 Monday thru Friday 9:00am to 1:00pm or email at Makingitalifestyle@gmail.com. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

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
• 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

[04/29/2016 - Press Release - Making It A Lifestyle, L.L.C.]