ST LOUIS (MD Consult) - On July 28, 2010, the US Food and Drug Administration (FDA) announced that Nutraloid Labs Inc is conducting a recall of certain lots of Ejaculoid XXTREME and Stimuloid II, products advertised as dietary supplements. The recall is occurring in response to results of an FDA product analysis that revealed the presence of sulfoaildenafil, an ingredient similar to sildenafil, which is an active ingredient in an FDA-approved drug for male erectile dysfunction. Sulfoaildenafil is not listed on the product labels, and the FDA considers these products unapproved drugs.
Ejaculoid XXTREME and Stimuloid II may interact with nitrates found in drugs such as nitroglycerin. Men using a combination of such products may experience dangerous drops in blood pressure.
The following table lists the products included in this recall:
|
Brand Name
|
Size
|
Lot
|
UPC
|
|
Ejaculoid XXTREME
|
30 Capsules/Bottle
|
79935 12/12
|
8 04879 17868 2
|
|
Stimuloid II
|
30 Capsules/Bottle
|
79936 12-12
|
8 04879 17867 5
|
Customers who have any of the above products in their possession are being told to immediately discontinue use and contact their physician if they have experienced any problems that may be related to taking these products. Health care professionals and patients are encouraged to report adverse events related to the use of these products to the FDA's MedWatch Program.
圣路易斯(MD Consult)——2010年7月28日，美国食品药品管理局(FDA)宣布，Nutraloid Labs 公司正开展对某些批次的Ejaculoid XXTREME和Stimuloid II的召回工作，这两种产品在广告中被宣称为膳食补充剂。此召回举措是回应FDA的产品分析结果而做出的。FDA产品分析揭示此产品中存在sulfoaildenafil——一种西地那非类似物，此成分是 FDA批准用于治疗勃起功能障碍(ED)药品的有效成分。Sulfoaildenafil在产品的说明书中未被列出，故FDA将这类产品视为未获准的药品。
Ejaculoid XXTREME和Stimuloid II可能与硝酸甘油等药品中的硝酸盐发生相互作用。男性联用这类药物后可出现血压危险性下降。
此次召回令中涉及的药品如下表所示：
|
商品名
|
规格
|
批次
|
UPC
|
|
Ejaculoid XXTREME
|
30 粒胶囊/瓶
|
79935 12/12
|
8 04879 17868 2
|
|
Stimuloid II
|
30粒胶囊/瓶
|
79936 12-12
|
8 04879 17867 5
|
FDA告知存有上述产品的消费者立即停用，若出现与服用这些产品相关的任何问题，联系其保健医生。提倡医护专业人士和患者将与使用这些产品相关的不良事件报告至FDA的MedWatch Program。
