Standard Process因担心沙门氏菌感染而召回3种膳食补充剂
圣路易斯(MD Consult)——2012年6月29日,美国食品药品管理局(FDA)宣布,Standard Process公司正在主动召回以下3种膳食补充剂:
• Cataplex ACP(产品#0700和0750,批号114);
• Cataplex C(产品#1650和1655,批号114);
• Pancreatrophin PMG(产品#6650,批号114)。
之所以发起这次召回,是由于在FDA常规记录检查中发现这些产品中的1种成分可能含有沙门氏菌。
这些产品均为片剂,分装在60 ml和200 ml琥珀色玻璃瓶中,最佳使用时间为2013年5月之前,这一指定日期同时标注在药瓶和包装盒上。其他产品或其他批号的上述产品未受影响。
Standard Process未收到任何与这些产品相关的疾病报告。此外,该公司利用其完善的微生物学实验室,对保存的样品进行了检测,结果未发现沙门氏菌。
沙门氏菌可在年幼儿童、体弱者或老年人,以及其他免疫功能低下者中引起严重甚至致命的感染。人感染沙门氏菌后通常会出现发热、腹泻(可能为血便)、恶心、呕吐和腹痛。在罕见情况下,沙门氏菌感染可导致这种病原菌进入血液并引起更严重的疾病,如动脉感染、心内膜炎和关节炎。
爱思唯尔 版权所有
ST LOUIS (MD Consult) - On June 29, 2012, the US Food and Drug Administration (FDA) announced that Standard Process Inc is conducting a voluntary recall of the following 3 dietary supplements:
•Cataplex ACP (product# 0700 and 0750, lot 114);
•Cataplex C (product# 1650 and 1655, lot 114); and
•Pancreatrophin PMG (product# 6650, lot 114).
This recall was prompted by a routine FDA record inspection that revealed that 1 of the ingredients used in these products potentially contained the bacteria Salmonella.
The products, all tablets, were distributed in 60-cc and 200-cc amber glass bottles with best used by dates of 5/13, with the dates indicated on both the bottles and the boxes. No other products or lot numbers are affected.
Standard Process has not received any reports of illness related to these products. In addition, Standard Process, which has a complete microbiologic laboratory on their premises, has tested retained samples of these products for Salmonella and the bacteria has not been found.
Salmonella can cause serious and sometimes fatal infections in young children, frail or elderly persons, and others with immune-system compromise. Persons infected with Salmonella often experience fever, diarrhea (which may be bloody), nausea, vomiting, and abdominal pain. In rare circumstances, infection with Salmonella can result in the organism entering the bloodstream and producing more severe illnesses such as arterial infections, endocarditis, and arthritis.
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来源: MDC
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