摘要：

　　2016-01-06召回的是250ml的0.9%的氯化钠注射液，因为有位患者抱怨在输液中发现了昆虫。

　　今年该公司进行多次召回：

　　十月份该公司还召回140,000袋氯化钠注射液，因为担心含有霉菌

　　七月召回了两批产品，因为经证明微粒为昆虫。

　　四月召回了600,000袋产品

　　具体链接如下：

　　http://www.fiercepharmamanufacturing.com/story/Baxter-recalls-more-its-saline-solutions-after-bug-was-found/2016-01-06

　　FROM: FiercePharma Manufacturing

　　January 6, 2016,by Joseph Keenan

　　More woes for the U.S. supply of saline solution as Baxter International ($BAX) announced another voluntary recallof its products. This time, twolotsof intravenous solutions have been recalled due to the presence of particulate matterafter a customer complained of an insect found in the product, 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，

　　The lots being recalled are for 0.9% sodium chloride injection,USP,250-milliliter Viaflex plastic container used for IVs and 70% dextroseinjection (2,000 milliliter) USP. Both products are typically used for caloricintake and hydration 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。

　　Using the product could result in blood vessel blockage, which can cause astroke, heart attack or damage to other major organs as well as possibleallergic reactions.

　　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。

　　The recall isn't expected to affect current supply and product remainsavailable for current 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。

　　In October, the Deerfield, IL, company recalled nearly 140,000 bags ofsodium chloride due to the possibility some of the saline solution bagscontained mold. That voluntary recall was initiated after Baxter received acomplaint of mold on the 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 number of problems, including 20 nonconformance reports onliquid products containing everything 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。

　　For about three years now, the U.S. has been battling shortages of saline,one of the most frequently used products in hospitals. To help replenish thenation's supply chain, it has allowed the import of product from some plants inEurope that were not previously approved for U.S. distribution. A Baxter plantin Spain was approved last year, and the agency has also granted temporarypermission to a Fresenius Kabi plant in Norway anda B. Braun plant in 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Fresenius Kabi工厂，以及德国的B. Braun工厂。

　　However, repeated recalls by Baxter and Hospira have kept the U.S.supply chain from getting fully replenished. Baxter has had a number of recallsof saline this year amounting to hundreds of thousands of bags. One recall ofthree lots in April last year alone accounted for 600,000 bags of product. Itrecalled two lots in July because of particulate that turned out 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。