被 发 现 含 有 未 标 示 西 药 的 产 品
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| The United States: Fat Burners Zone issues voluntary nationwide recall of Zero Xtreme due to presence of undeclared sibutramine (English Only) |
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The US Food and Drug Administration (FDA) announces that Fat Burners Zone is voluntarily recalling one lot of Zero Xtreme capsules to the consumer level. FDA analysis has found Zero Xtreme to be tainted with sibutramine. Sibutramine is an appetite suppressant that was withdrawn from the US market due to safety concerns. The presence of sibutramine in Zero Xtreme renders it an unapproved drug for which safety and efficacy has not been established and, therefore, subject to recall.
This tainted product is marketed as a dietary supplement for weight loss and is packaged in gray aluminum bottles with gray aluminum capsules, 30 capsules per bottle. The affected Zero Xtreme lot, #1220062085, expires 03/2020. Zero Xtreme was distributed nationwide via internet through the website fatburnerszone.com.
Sibutramine is the active pharmaceutical ingredient in Meridia, a new drug approved by FDA for marketing in 1997 for prescription treatment of obesity and, subsequently, withdrawn from the US market on 21 Dec 2010, after clinical data indicated sibutramine poses an increased risk of heart attack and stroke. 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. To date, Fat Burners Zone 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/ucm623503.htm
In Hong Kong, the above product is not a registered pharmaceutical product.
Ends/Tuesday, Oct 16, 2018
Issued at HKT 15:00
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