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“ouryaoinfo”蒲公英微信公众号2016年共发布文章2345篇，总字数485万字，累计阅读近1100万人次，发布天数365天（全年共366天）。在蒲公英论坛各位蒲友的支持下，2016年蒲公英微信运营团队取得了优异的成绩，2017向各位蒲友继续征稿，欢迎关注！ 【上海凌致赞助发布】蒲公英微信排行榜统计2016年阅读量过万的文章144篇，所有作者均将获得上海凌致独家提供的赞助奖品。 今日发布第143号作品： 题目：原文翻译：发现一只虫子，百特召回更多氯化钠注射液 作者：julia朱玉姣 内容： Baxter recalls more ofits saline solutions aftera bug was found 发现一只虫子，百特召回更多氯化钠注射液 http://www.fiercepharmamanufacturing.com/story/baxter-recalls-more-its-saline-solutions-after-bug-was-found/2016-01-06 FROM:FiercePharma Manufacturing January6, 2016,by Joseph Keenan Morewoes for the U.S. supply of saline solution as Baxter International ($BAX)announced another voluntary recallof its products. This time, two lots ofintravenous solutions have been recalled due to the presence ofparticulate matterafter a customer complained of an insect found in theproduct, the FDA said. 由于百特自愿召回其产品，美国氯化钠注射液供应陷入危机。据FDA说，在客户投诉在其产品中发现一只虫子后，此次有两批静脉注射液由于发现颗粒异物而召回， Thelots being recalled are for 0.9% sodium chloride injection, USP,250-milliliterViaflex plastic container used for IVs and 70% dextroseinjection (2,000milliliter) USP. Both products are typically used for caloricintake andhydration of patients. The lots were distributed in the U.S. betweenJune 6 and Dec.16 last year. 所召回的产品是0.9%的氯化钠注射液，USP级，250ml的Viaflex塑料包装，用于静脉注射和70%葡萄糖注射液（2000ml）USP级。这两种产品通常用于患者补充能量和补水。这些批次是在去年6月6日至12月16日之间在美国销售的。 Usingthe product could result in blood vessel blockage, which can cause astroke,heart attack or damage to other major organs as well as possibleallergicreactions. 使用该产品可能会导致静脉血管阻塞，从而引发休克，心脏病发作或损害其它主要器官，以及可能的过敏反应。 Therecall isn't expected to affect current supply and product remainsavailable forcurrent customers, the agency said. 官方说，召回不会对现有供应造成影响，现有客户仍可以获得该类产品。 InOctober, the Deerfield, IL, company recalled nearly 140,000 bags ofsodiumchloride due to the possibility some of the saline solution bagscontained mold.That voluntary recall was initiated after Baxter received acomplaint of mold onthe interior surface of an overpouch, which was made atits plant in Jayuya,Puerto Rico. That facility got an FDA warning letter twoyears ago for a numberof problems, including 20 nonconformance reports onliquid products containingeverything from skin to human hair to rayon. 在10月，在DEERFIELD，公司曾召回近14万袋氯化钠溶液，因为可能有一部分盐溶液袋被霉菌污染。上次的自愿招架是在百特收到一份投诉后发起的，该投诉说在一个袋子的内表面上发现有霉。那个工厂在2年前曾收到FDA发出的警告信，警告信说在工厂发现很多问题，包括20个关于液体药品含有杂七杂八东西的不符合报告，从皮肤到人体头发到人造丝。 Forabout three years now, the U.S. has been battling shortages of saline,one ofthe most frequently used products in hospitals. To help replenish thenation'ssupply chain, it has allowed the import of product from some plants inEuropethat were not previously approved for U.S. distribution. A Baxter plantin Spainwas approved last year, and the agency has also granted temporarypermission toaFresenius Kabi plantin Norway anda B.Braun plantin Germany. 在过三年里，美国都在和盐溶液短缺作斗争。氯化钠盐溶液是医院里最常用的药品。为了帮助补充国家供应链，已经允许从一些欧洲工厂进口该药品，这些药厂之前并没有被批准在美国销售。百特的一家在西班牙的工厂在去年被批准，FDA还颁发了临时许可给挪威的FreseniusKabi工厂，以及德国的B. Braun工厂。 However,repeated recalls by Baxter and Hospira havekept the U.S.supply chain from getting fully replenished. Baxter has had anumber of recallsof saline this year amounting to hundreds of thousands ofbags. One recall ofthree lots in April last year alone accounted for 600,000bags of product. Itrecalled two lots in July because of particulate that turnedout to be insects. 但是，百特和Hospira不断的召回使得美国供应链无法得到全面补充。百特在今年已宣布自愿召回了千万袋药品了。仅去年4月一次召回的3个批次就有60万袋。在7月还召回了2个批次，原因是发现颗粒物，而最后识别为昆虫。
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发表于 2017-2-20 09:57:54
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