一波未平一波又起！雷尼替丁再出问题，又一药企选择召回！

五个月前，也就是2019年8月，FDA扩大了对市场上的仿制药中杂质的调查。在9月13日FDA发布安全警告，表示了解到一些雷尼替丁药物，其中也包括品牌药Zantac，这些药物含有N-二甲基亚硝胺（NDMA）杂质。在安全警告发布后，多个跨国药企自愿召回产品，其中瑞迪博士药厂暂停其雷尼替丁药物在全球的供应，直至FDA调查结束；山德士公司自愿召回美国境内的所有受影响的有效期内的雷尼替丁批次；加拿大的 Apotex 制药公司自愿召回75mg和150mg的雷尼替丁片，并公布了受影响的批次；葛兰素史克自愿召回其包括印度在内全球市场销售的雷尼替丁药物。

今日，据FDA发布的消息，A ppco制药公司生产的盐酸雷尼替丁发现NDMA浓度超标，宣布自愿召回150 mg和300 mg所有批次的盐酸雷尼替丁胶囊，以下是FDA发布的公告全文及翻译。

Company Announcement

公司公告

Appco Pharma LLC (Appco) is voluntarily recalling all quantities and lots, within expiry, of Ranitidine Hydrochloride Capsules to the Consumer level. Ranitidine Hydrochloride Capsules are being recalled because of the presence or potential presence of N-nitrosodimethylamine (NDMA) levels above the acceptable daily intake levels established by the FDA, based on FDA-validated tests. To date, Appco has not received any reports of adverse events related to use of the product as part of this recall.

Appco Pharma LLC（Appco）自愿向消费者召回所有批次的盐酸雷尼替丁胶囊。盐酸雷尼替丁胶囊被召回是因为存在或潜在存在的N-亚硝基二甲胺（NDMA）浓度高于FDA试验确定的每日可接受摄入量水平。到目前为止，Appco尚未收到任何与本次召回产品使用相关的不良事件报告。

Risk Statement: NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.

风险声明：根据实验室测试结果，NDMA被归类为可能的人类致癌物（一种可能致癌的物质）。NDMA是一种已知的环境污染物，存在于水和食物中，包括肉类、乳制品和蔬菜。

Ranitidine Hydrochloride in strengths of 150 mg and 300 mg, is a prescription-only oral medication indicated for the treatment of duodenal ulcer, benign gastric ulcer, reflux esophagitis, post-operative peptic ulcer, Zollinger-Ellison Syndrome, and other conditions where reduction of gastric secretion and acid output is desirable.

本次召回的盐酸雷尼替丁的规格为150 mg和300 mg，这种药品是一种处方药，用于治疗十二指肠溃疡、良性胃溃疡、反流性食管炎、术后消化性溃疡、卓艾综合症等其他需要减少胃酸分泌的疾病。

The products subject to recall are listed below and are packaged in bottles. The product can be identified by checking the product name, count/bottle, manufacturer details and batch or lot number on the bottle containing these products.

需要召回的产品列在下面，为瓶装产品。可通过检查包含这些产品的瓶子上的产品名称、数量，或者制造商详细信息和批次或批号来识别产品。

Ranitidine Capsules 150 mg & Ranitidine Capsules 300 mg were distributed nationwide.

150mg和300mg的雷尼替丁胶囊在全美范围内销售。

Appco is notifying their marketing partner (ANI Pharmaceuticals, Inc.) by phone, email or other communication with recall notification communication. ANI Pharmaceuticals Inc., on behalf of Appco Pharma LLC, will be notifying its distributors and customers by phone and in writing to immediately discontinue distribution of the specific lots being recalled and to notify their sub-accounts. Appco is arranging for return of all recalled products to ANI Pharmaceuticals, Inc. Instructions for returning recalled products are given in the recall letter. Anyone with an existing inventory will be asked to immediately stop distribution and return any stock to ANI Pharmaceuticals, Inc. by contacting Stephen Bitter at [e-mail] or 218-634-3655 (between 8 to 5PM CST). All the recalled product shall be sent to:

Appco正在通过电话、电子邮件或其他召回通知的方式通知营销合作伙伴ANI Pharmaceuticals，Inc.。ANI制药公司将代表Appco 制药公司通过电话和书面方式通知经销商和客户，立即停止对召回的特定批次的销售，并通知其子账户。Appco正在安排将所有召回产品退回ANI制药公司。召回函中给出了退回召回产品的说明。任何人和现有库存将被要求立即停止销售，并通过联系Stephen Bitter返还所有库存到ANI制药公司。所有召回产品应发送至：

ANI Pharmaceuticals

Attn: Stephen Bitter

210 Main Street West

Baudette, MN 56623

Consumers that have product which is being recalled should stop using/return to place of purchase and speak to their physician or pharmacist about alternate healthcare treatment options.

拥有被召回产品的消费者应停止使用，返回购买地，并向其医生或药剂师咨询替代治疗方案。

Consumers with questions regarding this recall can contact Appco at: [phone] between 8 am and 6 pm (EST) (Monday-Friday) or e-mail: [e-mail] or at ANI Pharmaceuticals, Inc. at 1-800-308-6755 or [e-mail]. Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to taking or using this drug product.

消费者如对本次召回有任何疑问，可以联系Appco制药公司。如果消费者遇到任何可能与服用或使用本药品有关的问题，应联系他们的医生或医疗保健提供者。

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.

使用本产品出现的不良反应或质量问题可通过在线、邮件或传真向FDA报告。

Complete and submit the report Online在线完成并提交报告

Regular Mail or Fax: Download form 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

This recall is being conducted with the knowledge of the U.S. Food and Drug Administration.

此次召回是在FDA知情的情况下进行的。

参考来源：Appco Pharma LLC Issues Voluntary Nationwide Recall of Ranitidine Hydrochloride Capsules 150 mg and 300 mg Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)