一波未平一波又起！雷尼替丁再出問題，又一藥企選擇召回！來源：藥智網|一個桃子五個月前，也就是2019年8月，FDA擴大了對市場上的仿制藥中雜質的調查。在9月13日FDA發布安全警告，表示了解到一些雷尼替丁藥物，其中也包括品牌藥Zantac，

一波未平一波又起！雷尼替丁再出問題，又一藥企選擇召回！

來源：藥智網|一個桃子

五個月前，也就是2019年8月，FDA擴大了對市場上的仿制藥中雜質的調查。在9月13日FDA發布安全警告，表示了解到一些雷尼替丁藥物，其中也包括品牌藥Zantac，這些藥物含有N-二甲基亞硝胺（NDMA）雜質。在安全警告發布后，多個跨國藥企自愿召回產品，其中瑞迪博士藥廠暫停其雷尼替丁藥物在全球的供應，直至FDA調查結束；山德士公司自愿召回美國境內的所有受影響的有效期內的雷尼替丁批次；加拿大的 Apotex 制藥公司自愿召回75mg和150mg的雷尼替丁片，并公布了受影響的批次；葛蘭素史克自愿召回其包括印度在內全球市場銷售的雷尼替丁藥物。

今日，據FDA發布的消息，A ppco制藥公司生產的鹽酸雷尼替丁發現NDMA濃度超標，宣布自愿召回150 mg和300 mg所有批次的鹽酸雷尼替丁膠囊，以下是FDA發布的公告全文及翻譯。

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）自愿向消費者召回所有批次的鹽酸雷尼替丁膠囊。鹽酸雷尼替丁膠囊被召回是因為存在或潛在存在的N-亞硝基二甲胺（NDMA）濃度高于FDA試驗確定的每日可接受攝入量水平。到目前為止，Appco尚未收到任何與本次召回產品使用相關的不良事件報告。

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.

風險聲明：根據實驗室測試結果，NDMA被歸類為可能的人類致癌物（一種可能致癌的物質）。NDMA是一種已知的環境污染物，存在于水和食物中，包括肉類、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.

本次召回的鹽酸雷尼替丁的規格為150 mg和300 mg，這種藥品是一種處方藥，用于治療十二指腸潰瘍、良性胃潰瘍、反流性食管炎、術后消化性潰瘍、卓艾綜合癥等其他需要減少胃酸分泌的疾病。

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.

需要召回的產品列在下面，為瓶裝產品。可通過檢查包含這些產品的瓶子上的產品名稱、數量，或者制造商詳細信息和批次或批號來識別產品。

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

150mg和300mg的雷尼替丁膠囊在全美范圍內銷售。

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 stephen.bitter@anipharmaceuticals.com or 218-634-3655 (between 8 to 5PM CST). All the recalled product shall be sent to:

Appco正在通過電話、電子郵件或其他召回通知的方式通知營銷合作伙伴ANI Pharmaceuticals，Inc.。ANI制藥公司將代表Appco 制藥公司通過電話和書面方式通知經銷商和客戶，立即停止對召回的特定批次的銷售，并通知其子賬戶。Appco正在安排將所有召回產品退回ANI制藥公司。召回函中給出了退回召回產品的說明。任何人和現有庫存都將被要求立即停止銷售，并通過聯系Stephen Bitter返還所有庫存到ANI制藥公司。所有召回產品應發送至：

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.

擁有被召回產品的消費者應停止使用，返回購買地，并向其醫生或藥劑師咨詢替代治療方案。

Consumers with questions regarding this recall can contact Appco at: (732) 253-7735 between 8 am and 6 pm (EST) (Monday-Friday) or e-mail: pv@appcopharma.com or at ANI Pharmaceuticals, Inc. at 1-800-308-6755 or PVSupport@safetycall.com. 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.

消費者如對本次召回有任何疑問，可以聯系Appco制藥公司。如果消費者遇到任何可能與服用或使用本藥品有關的問題，應聯系他們的醫生或醫療保健提供者。

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.

使用本產品出現的不良反應或質量問題可通過在線、郵件或傳真向FDA報告。

Complete and submit the report Online在線完成并提交報告

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知情的情況下進行的。

參考來源：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)