Weight Loss Supplements RECALLED
Making It A Lifestyle, L.L.C. Issues a Voluntary Nationwide Recall of 3rd Degree, Black Gold X Advanced, and Black Label X Due to the Presence of Undeclared Sibutramine and Sildenafil
Corpus Christi, TX – 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. To date, Making It a Lifestyle has not received any reports of adverse events related to this recall.
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.
Consumers who have the recalled products should stop using them. The recalled products were distributed from February 2015 to April 27th 2016.