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Botanical Be召回多个品牌的膳食补充剂

Botanical-Be Recalls Dietary Supplements Under Multiple Brands

RTTNews 等信源发布 2023-10-25 00:51

可切换为仅中文


El Paso, Texas-based Botanical-Be is recalling certain dietary supplements under multiple brands citing the presence of undeclared Diclofenac, the U.S. Food and Drug Administration said.The recall involves all lots of Kuka Flex Forte, Artri King, and Reumo Flex capsules to the consumer level. These products are marketed as a dietary supplement for relief of pain and inflammation associated with arthritis.Artri king was distributed in bottles with 100 capsules, Kuka Flex with 30 capsules, and Reumo flex with 30 capsules.The affected Artri King comes with lot 35421 and an expiration date of December 19, 2025.

美国食品和药物管理局表示,德克萨斯州El Paso的植物学家Be正在召回多个品牌的某些膳食补充剂,理由是存在未申报的双氯芬酸。召回涉及所有批次的Kuka Flex Forte,Artri King和Reumo Flex胶囊到消费者水平。这些产品作为膳食补充剂销售,用于缓解与关节炎相关的疼痛和炎症。Artri-king分为100粒胶囊,Kuka Flex 30粒胶囊和Reumo Flex 30粒胶囊。受影响的Artri King带来35421批,有效期为2025年12月19日。

The recall also includes all lots of Kuka Flex Forte with an expiration date of December 12, 2024, and UPC code 0736640810265; and all lots of Reumo Flex with an expiration date of October 20, 2024. These products were distributed across the United States through the internet.As per the FDA analysis, all these products are tainted with Diclofenac, an approved non-steroidal anti-inflammatory drug or NSAID.

召回还包括所有批次的Kuka Flex Forte,截止日期为2024年12月12日,UPC代码为0736640810265;以及所有批次的Reumo Flex,截止日期为2024年10月20日。这些产品通过互联网在美国各地分发。根据FDA的分析,所有这些产品都被双氯芬酸(一种经批准的非甾体抗炎药或NSAID)污染。

The agency noted that the presence of Diclofenac in Kuka Flex Forte, Artri King, and Reumo Flex renders them unapproved drugs for which safety and efficacy have not been established. Therefore, these products are subject to recall.Consumption of undeclared diclofenac may result in serious adverse events including cardiovascular, gastrointestinal, renal, and anaphylaxis in patients taking concomitant NSAIDs and/or anticoagulants, such as Warfarin, in those who have allergies to diclofenac, or those with underlying cardiovascular, gastrointestinal, renal, and hepatic illnesses..

该机构指出,Kuka Flex Forte,Artri King和Reumo Flex中双氯芬酸的存在使他们尚未获得安全性和有效性的未经批准的药物。因此,这些产品需要召回。消费未申报的双氯芬酸可能会导致严重的不良事件,包括伴有NSAIDs和/或抗凝剂(如华法林)的患者,对双氯芬酸过敏的患者,或患有心血管,胃肠道,肾脏的患者的心血管,胃肠道,肾脏和肝脏疾病。。

However, Botanical-Be has not received any reports of adverse events related to the recalled products to date.Consumers are urged to cease usage immediately and return them to the place of purchase.In similar recalls, Brooklyn, New York-based WEFUN Inc. in September called back 300 boxes of dietary supplement capsules for undeclared Sildenafil, an ingredient known as a Phosphodiesterase Inhibitor or PDE-5 inhibitor found in FDA-approved products to treat male erectile dysfunction.Inmar Supply Chain Solutions, LLC in late August recalled various FDA regulated products, including dietary supplements, stored at its Arlington, Texas Facility citing poor conditions including rodents and higher than required heat.For More Such Health News, visit rttnews.com For comments and feedback contact: editorial@rttnews.comBusiness News.

但是,迄今为止,植物学尚未收到任何与召回产品相关的不良事件报告。敦促消费者立即停止使用并将其送回购买地。在类似的召回中,位于纽约州布鲁克林的WEFUN Inc.于9月份召回了300盒膳食补充剂胶囊,用于未申报的西地那非,这是一种在FDA批准的产品中被称为磷酸二酯酶抑制剂或PDE-5抑制剂的成分,用于治疗男性勃起功能障碍。8月下旬,Inmar Supply Chain Solutions,LLC召回了各种FDA监管的产品,包括膳食补充剂,这些产品储存在德克萨斯州阿灵顿的工厂,理由是包括啮齿动物在内的恶劣条件和高于所需的热量。有关更多此类健康新闻,请访问rttnews.com获取评论和反馈联系:editorial@rttnews.comBusiness新闻。

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