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美国Natural Wellness公司召回膳食补充剂

   2010-03-31 美国FDA956
核心提示:食品伙伴网导读:2010年3月30日,美国Natural Wellness 公司警告消费者不要购买品名为MasXtreme、批号为 911035的膳食补充剂产

    食品伙伴网导读:2010年3月30日,美国Natural Wellness 公司警告消费者不要购买品名为MasXtreme、批号为 911035的膳食补充剂产品,原因是其中含有未标识的爱地那非(结构上类似于西地那非的物质)。

    原文报道:

FOR IMMEDIATE RELEASE -- March 30, 2010 - Natural Wellness is warning consumers not to purchase or consume the product known as MasXtreme, Lot# 911035. This product which is being marketed as a dietary supplement contains undeclared amounts of Aildenafil, as well as the drug Phentolamine which is an alpha-adrenergic blocker. Aildenafil is close in structure to Sildenafil and is expected to possess a similar pharmacological and adverse event profile. Sildenafil is the active pharmaceutical ingredient in an FDA-approved drug that is used to treat erectile dysfunction (ED). This may pose a threat to consumers because Aildenafil 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. Common side effects of Phentolamine include arrhythmia (abnormal heart rhythm) and tachycardia (rapid heart beat).

MasXtreme is sold in blister packs containing one (1) capsule. The product is distributed Nationwide by Natural Wellness Inc. This product is being promoted for increasing desire and sexual performance. The product is sold without medical prescription.

Consumers who have purchased MasXtreme tablets are urged to immediately discontinue their use and return the product to their place of purchase or directly to Natural Wellness Inc. at 440 S Federal Hwy, Suite 107, Deerfield Beach, FL 33441. Consumers with questions regarding this recall may contact the company at 954-570-6662 Monday through Friday 8 am to 4 pm. Consumers who have purchased this product and have medical concerns should consult with their health care providers.

Adverse reaction or quality problems experienced with the use of this product may be reported to the FDA’s MedWatch Adverse Event Reporting program online, by regular mail, or by fax. Online: www.fda.gov/MedWatch/report.htm1. Regular Mail: use postage-paid, pre-addressed Form FDA 3500 available at www.fda.gov/MedWatch/getforms.htm2. Mail to address on the pre-addressed form. Fax: 1-800-FDA-0178.

This recall is being conducted in cooperation with the U.S. Food and Drug Administration (FDA).

    详情见:http://www.fda.gov/Safety/Recalls/ucm206759.htm 




日期:2010-03-31
 
行业: 保健食品
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