ST LOUIS (MD Consult) - On August 10, 2010, Novacare LLC announced that it is voluntarily recalling products sold under the following names: Stiff Nights, Aziffa, Size Matters, Erex, Mojo, Hard Drive, Eyeful, Red Magic, Straight Up, Zotrex, Monster Excyte, WOW, Xaitrex, Verect, Prolatis, Xytamax, Maxyte, Libidinal, OMG, OMG45, and Zilex (with Golden Spear). The decision to conduct the recall was made after Novacare was informed by the US Food and Drug Administration (FDA) that the products appear to contain sulfoaildenafil, an analogue of sildenafil, an FDA-approved drug used for the treatment of erectile dysfunction.
Sulfoaildenafil is not listed as an ingredient on the product labels. The undeclared ingredient may interact with nitrates found in some prescription drugs (eg, nitroglycerin) and may lower blood pressure to dangerous levels. To date, no illnesses or adverse effects have been reported to Novacare in connection with the use of these products.
The recalled products were distributed in bottles and/or blister cards to retailers and via the Internet. All lots of the aforementioned products with manufacture or distribution dates up to and including June 17, 2010, are being recalled.
Consumers are being advised to contact their physician if they have experienced any problems that may be related to use of this product. Health care professionals and patients are encouraged to report adverse events related to product use to the FDA's MedWatch Program.
圣路易斯(MD Consult)——2010年8月10日,Novacare公司宣布自动召回以下列商品名出售的药品:Stiff Nights、Aziffa、Size Matters、Erex、Mojo、Hard Drive、Eyeful、Red Magic、 Straight Up、Zotrex、Monster Excyte、WOW、Xaitrex、Verect、Prolatis、Xytamax、Maxyte、Libidinal、OMG、OMG45以及 Zilex (带有 Golden Spear)。做出此次召回决定的起因是美国食品药品管理局(FDA)通知Novacare公司其产品中可能含有西地那非类似物sulfoaildenafil,而西地那非是FDA批准治疗勃起功能障碍的药物。
Sulfoaildenafil未作为药品成分列在产品说明书中。这种未申报的成分可能与某些处方药如硝酸甘油中的亚硝酸盐发生相互作用,使血压降至危险水平。迄今,Novacare公司尚未收到与使用上述药品有关的疾病或不良事件的报告。
被召回的药品以瓶装和(或)泡罩包装卡的形式分销至零售商,另外还通过网上销售。截止到2010年6月17日前(包括6月17日)生产或销售的所有批次的上述药品均在召回之列。
建议消费者在发生任何与使用这类药品有关的问题时联系其医生。提倡医护专业人士和患者将与药品使用有关的不良事件上报至FDA的 MedWatch Program。