FDA：普霖斯顿制药公司自愿召回通知

翻译：JULIA 来源：Julia法规翻译 

美国FDA官网通知链接https://www.fda.gov/Safety/Recalls/ucm613504.htm 

全文如下：

PrinstonPharmaceutical Inc Issues Voluntary Nationwide Recall of Valsartan andValsartan HCTZ Tablets Due to Detection of a Trace Amount of UnexpectedImpurity, N-Nitrosodimethylamine (NDMA) in The Products

普霖斯顿制药公司发布全国范围自愿召回通知，因在该药品中检出痕量非预期杂质N-二甲基亚硝胺（N-Nitrosodimethylamine，NDMA）召回缬沙坦和缬沙坦+氢氯噻嗪

For Immediate Release立即发布    July13, 2018

Contact

Consumers  SolcoCustomer Service  customerservice@solcohealthcare.com  1-866-931-9829

Announcement公告

Prinston Pharmaceutical Inc. dba Solco Healthcare LLC. is recalling all lots of Valsartan Tablets, 40 mg, 80mg, 160mg,   and 320mg; and Valsartan-Hydrochlorothiazide Tablets, 80mg/12.5mg, 160mg/12.5mg,160mg/25mg, 320mg/12.5mg, and 320mg/25mg to the retail level. This product recall is due to the detection of a trace amount of an unexpected impurity,N-nitrosodimethylamine (NDMA), made by the manufacturer – Zhejiang Huahai Pharmaceutical Co. Ltd. — that is used in the manufacture of the subject product lots. This impurity has been classified as a probable human carcinogenas per International Agency for Research on Cancer (IARC) classification.

普霖斯顿制药公司（以Solco保健公司名称运营）正在召回缬沙坦40mg、80mg、160mg和320mg片剂，以及缬沙坦+氢氯噻嗪80mg/12.5mg、160mg/12.5mg、160mg/25mg、320mg/12.5mg和 320mg/25mg片剂，召回直到零售层级。该产品召回是因为浙江华海制药有限公司—被召回的药品批次所用原料药生产商—发现痕量的非预期杂质–N-二甲基亚硝胺（N-Nitrosodimethylamine，NDMA）。该杂质已被国际癌症研究所（IARC）归类为可能的人体致癌物。

The products are indicated for the treatment of hypertension.

该产品适应症为高血压。

The exposure to the impurity N-nitrosodimethylamine (NDMA) that was detected in valsartan product line presents an unacceptable carcinogenic risk to the intended patient population. Todate,Prinston Pharmaceutical Inc. has not received any reports of adverse events related to this recall.

暴露于在缬沙坦中所检出的杂质N-二甲基亚硝胺（N-Nitrosodimethylamine，NDMA）中对于接受治疗的患者人群有着不可接受的致癌风险。截止今日，普霖斯顿制药公司并未收到任何与此次召回有关的不良反应报告。

The lot number and expiry date information can be found on the manufacturer’s unit (see photographs below of packaged product bottlelabels).

在生产商的单位包装上可以找到批号和有效期信息（参见以下包装产品瓶签图片）。

Retail pharmacies in possession of any unused products:Valsartan Tablets, 40 mg, 80mg, 160mg, and 320mg; and Valsartan-HCTZ Tablets,80mg/12.5mg, 160mg/12.5mg, 160mg/25mg, 320mg/12.5mg, and 320mg/25mg, within expiry dates from Jul 2018 to Jan 2020 should immediately return the product by following the instructions below:

零售药房如存有任何未使用的以下药品：缬沙坦40mg、80mg、160mg和320mg片剂，以及缬沙坦+氢氯噻嗪80mg/12.5mg、160mg/12.5mg、160mg/25mg、320mg/12.5mg和 320mg/25mg片剂，如有效期为201807-202001，则应立即按以下指示将药品退回：

• Please contact Solco Customer Service at 1-866-931-9829, Option 5, Monday through     Friday (9am to 5pm EST) or email or fax to: customerservice@solcohealthcare.com; 1- 866-931-0709, for the Product Return.

• 请联络Solco客服：周一至周五（早9点–晚5点EST时间）电话1-866-931-9829选5，或邮件或传真至customerservice@solcohealthcare.com; 1- 866-931-0709退回药品。

• A call tag, a pre-printed, pre-paid return label will be provided to you for     product return; return is free of charge.

• 公司会为你提供一张已打印并预付的运费付讫退货标签让你退回药品，退货为免费。

• Return     products to:
      DLSS (Dohmen Life Science Services) Attn: Returns Department
      4580 S. Mendenhall, Memphis, TN 38141

• 药品退回地址：DLSS（Dohmen生命科学服务），收件人：退货部，4580 S.     Mendenhall, Memphis,田纳西州 38141

Solco is notifying its distributors and customers by letter and email and is arranging for return of all recalled products. Pharmacies and wholesalers that received the impacted products will receive a letter as wellas a copy of this press release with their recall notification information.

Solco正在通过信件和邮件通知其分销商和客户，同时正安排所有召回药品的退货事宜。凡收到受影响药品的药房和批发商将会收到一封函件以及本通知的副本，其中有其召回通知信息。

If you have any questions regarding this recall, please call1-866-931-9829, Option 5, between the hours of 9:00 a.m. to 5:00 p.m. EST Monday through Friday. Consumers should contact  their physician or healthcare provider if they have experienced any problems that may be related to usingthis product. Additional information regarding this recall affected products’lots and expiry dates can be found athttp://www.solcohealthcare.com/uploads/news/ValsartanHCTZRecallAffactedLots.pdf or to download at http://www.solcohealthcare.com/uploads/news/ValsartanHCTZRecallAffactedLots.xlsx

如果你有任何关于此召回的问题，请在周一至周五EST时间上午9点至下午5点间拨打1-866-931-9829转5。消费者如经历可能与使用此药有关的任何问题，应联络其医生或医疗提供方。关于此次召回受影响药品批号和有效日期的更多信息可以上述链接找到。

（译者注：经下载该批号清单发现，共涉及有802个批次）

Adverse reactions or quality problems associated with theuse of this product may be reported to FDA’s MedWatch Adverse Event Reporting program either by phone, on line, by regular mail or by fax.

与此药品使用有关的不良反应或质量问题可电话、在线或邮件或传真报告至FDA的MedWatch不良反应报告中心。

• Complete and submit the report Online: www.fda.gov/medwatch/report.htm

• 在线完整填写并提交报告

• 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.

• 普通邮件或传真：从上述网址下载表格或拨打1- 800-332-1088索取报告表格，然后填写并返回表上所指地址，或传真至1-800-FDA-0178

This Product Recall is being made with the knowledge of the United States Food and Drug Administration (FDA).

美国FDA对该召回已尽其所知。

Product Photos药品图片

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