【分享】辉瑞出大事了！

爱家奔奔

http://www.fda.gov/Safety/Recalls/ucm388329.htm 官方网页版中文翻译 呵呵 练习英文用 仅供参考
Recall -- Firm Press Release
召回-公司新闻发布稿
FDA posts press releases and other notices of recalls and market withdrawals from the firms involved as a service to consumers, the media, and other interested parties. FDA does not endorse either the product or the company.
FDA会向消费者、媒体以及相关的利益方公告与召回相关的通知、新闻发布稿以及涉及召回公司的市场撤回等消息，但是并不代表FDA认可该产品或者该公司召回的行为。
Pfizer Initiates Nationwide Voluntary Recall of Two Lots of Pfizer’s Effexor XR® 150 Mg Extended-Release Capsules and One Lot of Greenstone’s Venlafaxine HCl 150 Mg Extended-Release Capsules Due to the Possible Presence of Tikosyn® Capsules
辉瑞发起全国性自主召回两个批次郁复伸（文拉法辛制剂）150mg缓释胶囊和一个批次150mg怡诺思缓释胶囊是由于其中可能混入多菲利特胶囊
Contact
Consumer:
1-888-345-0481
1-800-438-1985

Media:
MacKay Jimeson
1-212-733-2324
FOR IMMEDIATE RELEASE - March 6, 2014 - NEW YORK, NY – Pfizer Inc. is voluntarily recalling one lot of 30-count Effexor XR® (venlafaxine HCl) 150 mg extended-release capsules, one lot of 90-count Effexor XR (venlafaxine HCl) 150 mg extended-release capsules and one lot of 90-count Greenstone LLC-branded Venlafaxine HC1 150 mg extended-release capsules.
即时发布-2014年3月6日-纽约-辉瑞公司自主召回一批30-count150mg郁复伸（文拉法辛制剂）缓释胶囊，一批90-count150mg郁复伸（文拉法辛制剂）缓释胶囊，
，一批90-count以“Greenstone LLC”为品牌的150mg怡诺思（文拉法辛制剂）缓释胶囊，
This action is being taken because of a pharmacist report that one bottle of Pfizer’s Effexor XR contained one capsule of Tikosyn® (dofetilide) 0.25mg in addition to the Effexor XR capsules. Although Pfizer has not received any other such reports, these three lots are being voluntarily recalled as a precaution because they were packaged on the same line.
辉瑞采取此次召回行动是因为一位药剂师报告说在盛装辉瑞怡诺思（文拉法辛制剂）缓释胶囊的瓶子里发现一粒多菲利特胶囊。尽管辉瑞目前还没有接收到其它类似的报告，辉瑞还是决定自主召回这三批作为预防措施，因为这三个批次产品是在同一个包装线上完成包装的。
The use of Tikosyn by an Effexor XR/Venlafaxine HCl patient, where the contraindications and drug-drug interactions with Tikosyn have not been considered by the prescribing physician, could cause serious adverse health consequences that could be fatal.
接受辉瑞怡诺思（文拉法辛制剂）治疗的患者在服用多菲利特胶囊之后，可能由于药物之间的相互作用和禁忌症等处方医生没有考虑到的因素，而导致严重的不良反应甚至是致命的伤害。
While there is a very low probability that other bottles of Effexor XR contain a Tikosyn capsule, Pfizer has initiated this voluntary recall as a precaution.
虽然在其它的怡诺思瓶里出现多菲利特胶囊的可能性比较小，辉瑞仍然将此次自主性召回作为预防措施。
Effexor XR is a prescription antidepressant indicated for the treatment of major depressive disorder, general anxiety disorder, social anxiety disorder, and panic disorder with or without agoraphobia. Tikosyn is a Class III (cardiac action potential duration prolonging) antiarrhythmic drug. It is used to treat irregular heartbeats (such as atrial fibrillation (AF) and atrial flutter (AFL)) and to maintain normal sinus rhythm (normal heartbeat) in patients with AF or AFL of greater than one week duration who have been converted to normal sinus rhythm.
辉瑞怡诺思是一个处方抗抑郁药，用于治疗重度抑郁症，广泛性焦虑症，社交焦虑症，恐慌症或者伴随广场恐怖症。多菲利特胶囊是三类抗心律失常药物（心脏动作电位持续延长）。它用于治疗心跳无规律（心房颤动和心房扑动）和持续一个星期以上心房颤动或心房扑动的患者来维持正常心窦性节律。
This recall is to the patient level and involves Pfizer lot numbers V130142 and V130140, which both expire in October 2015, and Greenstone lot number V130014, which expires in August 2015.
此次召回涉及辉瑞产品批号为V130142和批号V130140，两者有效期至2015年10月，绿石品牌批号为V130014，有效期至2015年8月。
These products were distributed nationally to wholesalers, distributors, certain government agencies, patient assistance programs and retailers, such as pharmacies and hospitals. These direct customers are being notified by UPS next day mail, and Pfizer is arranging for the return of all recalled products.
这些产品在全国范围内分发到批发商、经销商、某些政府机构、以及患者服务机构如药房和医院。辉瑞将以UPS次日达邮件的方式通知这些直接客户，并在安排所有召回产品的接收问题。
Wholesalers, distributors, government agencies, patient assistance programs and retailers with product that is being recalled should stop distribution and promptly return the product to Stericycle Inc. Please contact Stericycle at 1-888-345-0481 for instructions on returning product.
批发商、经销商、政府机构、患者辅助组织如药房和医院对于正在召回的产品应立即停止分发，将产品发还给Stericycle Inc。对于召回产品的详细说明请通过1-888-345-0481联系Stericycle Inc。
Pharmacists should immediately quarantine, discontinue distribution of and return all recalled lots of these products, as well as notify any of their customers to whom they distributed the products. Patients with affected product should notify their physicians and/or return product to their pharmacies.
药剂师应立即将召回产品进行隔离，停止发放相关药品，并召回所有相关的药品，并及时通知患者归还药品。持有受影响批次的药品的患者应该立即通知各自的药剂师并将药品归还到药房。
Patients with questions regarding the return of product should contact Stericycle at 1-888-345-0481 (Monday to Friday 8am to 5pm ET). Patients with questions regarding this recall can contact Pfizer Medical Information at 1-800-438-1985 (Monday to Thursday 9am to 8pm ET or Friday, 9am to 5pm ET).
对于召回产品有疑问的患者可以通过1-888-345-0481联系Stericycle（周一至周五上午8点至下午五点）。对于此次召回有疑问的患者可以直接通过1-800-438-1985联系辉瑞药学信息部（周一至周三上午9点至下午8点，周五上午九点至下午5点）
Patients should contact their physician or healthcare provider if they have experienced any problems that may be related to taking this drug product.
患者如果在服用相关药物遭遇任何问题时可以联系各自的药剂师或者保健服务提供者。
Adverse reactions or quality problems experienced with the use of this product may be reported to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.
服用该种药物导致的不良反应或者质量问题时，患者可以通过在线、邮件或者传真的方式报告给FDA医疗观察不良反应报告组织。
•        Complete and submit the report online: www.fda.gov/medwatch/report.htm
•        在www.fda.gov/medwatch/report.htm网站上完成和提交不良反应报告。
•        Download form www.fda.gov/MedWatch/getforms.htm or call 1-800-332-1088 to request a reporting form, then complete and return to the address on the pre-addressed form, or submit by fax to 1-800-FDA-0178
•        在www.fda.gov/MedWatch/getforms.htm下载表格，或者是致电1-800-332-1088索取表格，填写完毕然后邮寄或者通过传真到1-800-FDA-0178。
Tikosyn can cause serious side effects, including a type of abnormal heartbeat called Torsade de Pointes, which can lead to death. If an Effexor XR/Venlafaxine HCl patient thinks they may have mistakenly ingested a Tikosyn capsule, they should immediately contact their physician or hospital. Patients should also watch for signs of abnormal heartbeat, and inform their physician or hospital if they
•        feel faint
•        become dizzy, or
•        have a fast heartbeat
多菲利特胶囊可能引起严重的不良反应，包括不正常的心跳，被称之为室性心动过速，可导致死亡。如果怡诺思患者错误服用了一颗多菲利特胶囊，患者应该立即联系各自的医生或者是医院。患者还应该监测是否有异常心跳的症状，通知他们的医生或者是医院如果他们感觉头晕、眩晕、或者是心跳加快。
Pfizer has responded rapidly to this situation to ensure the safety of patients who take our medicines. This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.
辉瑞公司已经对此类情况快速做出反应，以确保服用药物的患者的安全。此次召回行动是在告之美国FDA组织的前提下进行的。
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随风飘逝

看热闹的不怕事大，但召回是我见过最小的事了

左司马

大公司也会出现混药这种事。可见，不管你是否通过cGMP、欧盟GMP、其它的什么P，它一样会出问题。所以，也不要迷信过了什么外国的P就了不得了。但是，人家遇到问题愿意及时解决、补救，这个态度值得肯定和学习！

力菲

看怎么处理

爱雨山

混药，很大的纰漏啊！

墨石

辉瑞？也和其他外企一样，双重标准。

gongpu

ZetaMKII 发表于 2014-3-11 09:00
什么负责任，出现混药事件，这足以说明其GMP管理有漏洞， 本来就有责任；
不主动召回，患者告倒，赔偿费 ...

不得已而为之？！

aslwb

这种药企出现混淆的现象，风险很高哦！

Enjoy

出这种事，国内的企业就不召回么？对华的双重标准全忘了吧……

胜利者

此种混淆较为严重

qdy

主动召回是出于责任，支持。

:-O夢醉西樓ゞ☆

龙少爷 发表于 2014-3-10 16:52
中国企业有这魄力就好了

为什么中国企业就没有呢？这是叫质量投诉，这如果上告到国监那边就是涉嫌假药要调销营业执照的，想来应该如果你是一个企业主你出会召回的，这种事用钱是很难摆平的，主要是这个事件曝光了，不然也不一定就是召回，再说了召回曝光后还不是在为他做免费广告，国外企业放的屁都是香的，要现在召回的是修正或哈药我看我们的同胞们就不一定会是这样的赞美了吧！因为咱都不相信自己人了。。。

fbcaaa

主动召回是件好事啊，这才是为了人类健康

wangjin1023

召回是出于谨慎考虑.做良心药

Whats

说明不要盲目崇拜老美，他们也有漏洞，但是风险管理机制还是值得借鉴。

善变的云

混药事件不可恕，主动召回合情理，亡羊补牢犹未晚，放任自流最可悲。

centrel

我看到的确实生产工厂的混乱程度。说句不客气的话，岂止会是两批有问题？？应该停产整顿。仅仅召回远远不够。                                    

centrel

qingkang 发表于 2014-3-10 16:35
召回是良心啊，亡羊补牢犹未晚也

中国先污染后治理的方式，你认为也是有良心么？

yougx

清洁不到位、混料在大公司也还是一样存在，共线生产又是不可避免的事情，行业的难题呀...

淡绿

主动召回就是好的，降低重大损失。{:soso_e163:}