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金属成分污染泰诺,强生子公司赔偿2500万美元

2015-03-12 13:36:30 来源:生物谷

2015年3月12日讯/生物谷BIOON/--强生旗下麦克尼尔公司因售卖金属成分污染的泰诺液体制剂(Tylenol)被起诉,美国司法部门介入,宣判麦克尼尔赔偿2500万美元。麦克尼尔公司对这项刑事指控表示认罪伏法。

这次金属粒子污染事件始于2009年5月份,有一位消费者投诉婴幼儿泰诺药瓶底部有“黑斑”,经检查,这些黑斑是镍和铬颗粒。

2010年,麦克尼尔因质量缺陷紧急召回大批儿童OTC药物,比如婴幼儿专用泰诺以及儿童布洛芬制剂,都产自华盛顿堡,宾夕法尼亚工厂。

从2008年到2010年,麦克尼尔发生过多次产品召回事件,而且都是知名品牌,比如泰诺、布洛芬、罗雷兹、苯那君等等,召回原因都是生产过程出现纰漏,产品质量不合格。每次召回事件都引起大范围的轰动,强生名誉也连连受损。

除了金属离子污染,还有药物发霉、标签错误等问题。用于过敏症的Sudafed就曾发生标签错误,一句话中连续印刷了两个“not”。

2010年,强生在美国市场的销售额下跌至少19%,减少了9万美元。这是强生自第二次世界大战以来在美国的业绩首次下滑,而罪魁祸首就是2009年和2010年的产品质量问题。

麦克尼尔发言人Carol Goodrich在辩诉辞中说他们会把这次的事件当作一个新起点,做好整个产业链的质量工作,提高监管标准。在重开华盛顿堡工厂之前会采取更完善的安全措施。

英文原文:Tylenol maker to pay $25 million for selling metal-contaminated drugs

Tweet inShare.9Share thisEmailPrintWASHINGTON (Reuters) - A Johnson & Johnson subsidiary pleaded guilty on Tuesday to selling liquid medicine contaminated with metal and agreed to pay $25 million to resolve the case, the U.S. Department of Justice said on Tuesday.

The subsidiary, McNeil Consumer Healthcare, pleaded guilty to one federal criminal charge in the case.

In 2010, the company launched mass recalls of certain children's over-the-counter-medicines, including Infants' Tylenol and Children's Motrin, made at its Fort Washington, Pennsylvania plant.

It was the latest in a series of recalls at the time. There were far-reaching multiple recalls from 2008 to 2010 involving hundreds of millions of bottles and packages of consumer brands such as Tylenol, Motrin, Rolaids, Benadryl and other products due to faulty manufacturing. The recalls kept widely used products such as Children's Tylenol off pharmacy shelves and seriously tarnished J&J's once-sterling reputation.

In addition to metal particles getting into liquid medicines, there were moldy odors and labeling problems. For example, the label for Sudafed allergy tablets incorrectly repeated the word "not" to say "do not not divide, crush, chew or dissolve the tablet."

In the case involving metal particles, the troubles began in May 2009 when a consumer complained after noticing "black specks" in the bottom of a bottle of Infants' Tylenol. The specks were found to be nickel and chromium particles.

In 2010, Johnson & Johnson's U.S. consumer product sales fell by more than 19 percent, a decrease of $900 million. The rash of consumer medicine recalls in 2009 and 2010 were largely responsible for the first back-to-back years of company sales declines since World War Two.

Carol Goodrich, a spokeswoman for McNeil Consumer Healthcare, said the plea agreement "closes a chapter" and that the company has "been implementing enhanced quality and oversight standards across its entire business."

As part of the agreement, McNeil also agreed to further safety measures before reopening its Fort Washington facility.

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