Products found to contain undeclared medicines
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| The United States: 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 |
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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 Degree are marketed as weight loss dietary supplements, and 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. These products were distributed nationwide via internet.
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.
Please refer to the following website in FDA for details:
http://www.fda.gov/Safety/Recalls/ucm498455.htm
In Hong Kong, the above products are not registered pharmaceutical products. Related news was previously issued by the FDA, and was posted on the Drug Office website on 28 April 2016, and there is no registered pharmaceutical product manufactured by Making It A Lifestyle, L.L.C.
Ends/ Tuesday, May 03, 2016
Issued at HKT 15:00
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