TEVA在美国召回含缬沙坦药品

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Teva Pharmaceuticals USA Issues Voluntary Nationwide Recall of All Amlodipine/Valsartan Combination Tablets and Amlodipine/Valsartan/Hydrochlorothiazide Combination Tablets That Are Within Expiry

TEVA药业美国发布全国主动召回通知：召回所有效期内氨氯地平/缬沙坦复方片剂和氨氯地平/缬沙坦/氢氯噻嗪复方片剂

November 27, 2018

Teva Pharmaceuticals has initiated a voluntaryrecall in the United States, to the patient level, of all lots of Amlodipine /Valsartan combination tablets and Amlodipine / Valsartan / Hydrochlorothiazide combination tablets (see table below) due to an impurity detected above specification limits in an active pharmaceutical ingredient (API) manufactured by Mylan India. The impurity found in Mylan’s valsartan API is known as N-nitroso-diethylamine (NDEA), which has been classified as a probable human carcinogen. This chemical is typically found in very small amounts in certain foods, drinking water, air pollution, and certain industrial processes.

TEVA药业已启动美国全境主动召回至患者级别，召回所有批次氨氯地平/缬沙坦复方片剂和氨氯地平/缬沙坦/氢氯噻嗪复方片剂（见下表），原因是由MYLAN印度生产的API中检出杂质NDEA超出标准限度。NDEA被认为是可能的人体致癌物质，通常在特定食品、饮用水、空气污染物和特定工业加工中发现存在有极低数量。

Amlodipine/Valsartan combination tablets and Amlodipine/Valsartan/Hydrochlorothiazide combination tablets are used for the treatment of high blood pressure. To date, Teva has not received any reports of adverse events signaling a potential link or exposure to valsartan.

氨氯地平/缬沙坦复方片剂和氨氯地平/缬沙坦/氢氯噻嗪复方片剂用于治疗高血压。截止目前，TEVA尚未收到任何有潜在关联或暴露于缬沙坦的不良事件报告。

Patients taking Amlodipine / Valsartan combination tablets or Amlodipine / Valsartan / Hydrochlorothiazide combination tablets are advised to continue taking their medication and to contact their pharmacist or physician for advice on alternative treatment. The risk of harm to a patient’s health may be higher if the treatment is stopped immediately without any comparable alternative treatment.

建议正在服用氨氯地平/缬沙坦复方片剂和氨氯地平/缬沙坦/氢氯噻嗪复方片剂的患者继续服用其药品，并联系其药师或医生获得替代治疗建议。在没有对等替代治疗时立即中断治疗所带来的患者健康风险可能会更高。

Teva Pharmaceuticals USA is notifying its distributors and customers by certified mail and is arranging for return/reimbursement of returned recalled products.  Distributors and retailers that have product that is being recalled should immediately stop distribution and quarantine any quantities remaining in their control and return the recalled product.

TEVA药业美国正通过经认证的邮件通知其经销商和客户，并安排退货退款事宜。持有被召回药品的经销商和零售商应立即停止销售，并隔离所有受其控制的药品，将被召回药品退回。

Customers and patients with medical-related questions, information about an Adverse Event or other questions about the Teva products being recalled should contact Teva’s Medical Information by phone at:888-838-2872, option 3, then, option 4. Live calls are received Monday-Friday,9:00AM-5:00PM Eastern Time with Voicemail available 24 hours/day, 7 days/week or email druginfo@tevapharm.com.

客户和患者如有相关问题、不良事件信息或其它关于TEVA被召回药品的问题请联系TEVA药品问讯处，电话888-838-2872，选3再选4。人工服务时间为周一至周五9.00AM-5.00PM美国东部时间，声讯服务为全天候，亦可发送邮件。

Adverse reactions or other problems experienced with the use of the products may also be reported to Teva directly at 888-838-2872 or to the FDA's MedWatch Adverse Event Reporting program either online, by regular mail or by fax.

使用药品产生不良反应或其它问题亦可直接向TEVA报告，或向FDA药品不良事件监测中心在线或通过邮件或传真报告。

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm
• 上述网址在线填写并提交报告
• Regular Mail or Fax: 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
• 邮件或传真，下载表格或拨打1-800-332-1088获得报告表格，然后填写完成并发回表格内已有地址，或通过传真1-800-FDA-0178提交
  
  

Patient safety and product quality is critical toTeva. As always, Teva will continue to partner with, and regularly update, all relevant stakeholders, including regulatory authorities, to resolve this situation. This issue is not limited to valsartan medicines manufactured and distributed by Teva. Some valsartan-containing products manufactured and distributed by other pharmaceutical companies using the same API supplier may also be affected.

患者安全与药品安全是TEVA的首要关注。TEVA将一如既往继续与干系人包括药监机构合作并定期向其更新直到问题解决。此问题不仅限于TEVA生产和销售的缬沙坦药品。一些由其它制药公司生产和销售的含有缬沙坦的药品使用了相同的API生产商，可能亦会受到影响。

Lots Under Voluntary Recall 主动召回批次

The products that are part of this voluntary recalland listed below are packed in bottles. These lots were distributed nationwide to Teva’s Direct Accounts (Wholesale/Distributor/Retail/Repackagers/VAPharmacy, et. al).

此次主动召回的药品为瓶装，批号列出如下。这些批次在美国全境销售至TEVA的直接客户（批发/经销/零售/重新包装/VA药房等）。

本文摘自 Julia法规翻译