ST LOUIS (MD Consult) - On August 6, 2010, the US Food and Drug Administration (FDA) announced that EZVille, Ltd is recalling Solo Slim and Solo Slim Extra Strength products, both of which are marketed as dietary supplements for weight loss. The decision to conduct the recall was made after an FDA laboratory analysis of Solo Slim revealed that the product contains didesmethyl sibutramine. Sibutramine is an FDA-approved drug used as an appetite suppressant for weight loss, but the FDA has not approved Solo Slim. Therefore, the safety and effectiveness of the product is unknown.

The FDA believes that the use of Solo Slim poses a threat to consumers because sibutramine is known to substantially increase blood pressure and/or pulse rate in some patients. The product's use may present a significant risk for patients with a history of coronary artery disease, congestive heart failure, arrhythmias, or stroke. However, no illnesses or injuries have been reported to the company to date in connection with these products.

Solo Slim is packaged in white plastic bottles containing 30 capsules per bottle and bearing the Universal Product Code (UPC) 8 35470 00206 9. Solo Slim Extra Strength is packaged in white plastic bottles containing 30 capsules per bottle and bearing UPC 8 35470 00220 5. All lots of these products with expiration dates including and prior to August 2013 currently available on the market are being recalled. The company has discontinued distribution of the affected products.

Consumers are being advised to contact their physician if they have experienced any problems that may be related to use of these products. 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6日，美国食品药品管理局(FDA)宣布，EZVille公司正在召回其产品Solo Slim和 Solo Slim Extra Strength，这两种产品均作为减肥膳食补充剂在市场上销售。此次召回决定是在FDA实验室分析发现Solo Slim含有二去甲盐酸西布曲明(didesmethyl sibutramine)后作出的。西布曲明是FDA批准的一种抑制食欲的减肥药物，而Solo Slim未经FDA批准，因而其安全性和有效性尚不清楚。

FDA认为，服用Solo Slim可能会给消费者构成威胁，因为已知西布曲明可提高某些患者的血压和(或)脉搏。服用该产品可能会给冠状动脉疾病、充血性心衰、心律失常或卒中病史患者带来巨大风险。然而截至目前为止，该公司尚未收到有关该产品所导致疾病或伤害的报告。

Solo Slim为白色塑料瓶包装，每瓶含有30粒胶囊，并印有通用产品代码(UPC) 8 35470 00206 9；Solo Slim Extra Strength为白色塑料瓶包装，每瓶含有30粒胶囊，并印有UPC  8 35470 00220 5。目前市售的使用截止日期在2013年8月及其之前的所有批次产品均在召回之列。该公司已经停止相关产品的配送。

建议消费者一旦出现任何可能与该产品使用有关的问题时，应与医生联系。鼓励医护人员和患者向FDA MedWatch Program系统报告与该产品使用有关的不良事件。