Mylan N.V. today announced that its U.S. based Mylan Pharmaceuticals business is conducting a voluntary nationwide recall, to the consumer level, of three lots of Nizatidine Capsules, USP (including the 150mg and 300mg strengths). While Mylan has not received any reports of adverse events related to these batches to date, this product is being voluntarily recalled due to detected trace amounts of an impurity N-nitrosodimethylamine (NDMA) contained in the API Nizatidine, USP, manufactured by Solara Active Pharma Sciences Limited.
NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products and vegetables. NDMA has been classified as a probable human carcinogen (a substance that could cause cancer) according to the International Agency for Research on Cancer (IARC).
The finished products are manufactured by Mylan Pharmaceuticals Inc. These batches were distributed nationwide to wholesalers, mail order pharmacies, retail pharmacies, and a distributor between June 2017 and August 2018. The recalled batches are as follows:
Nizatidine is indicated for the short-term treatment (up to 8 weeks) of active duodenal ulcers and active benign gastric ulcers, as maintenance therapy for duodenal ulcer patients for up to one year, and for up to 12 weeks for the treatment of endoscopically diagnosed esophagitis and associated heartburn due to gastroesophageal reflux disease (GERD).
Mylan is notifying its distributors and customers by letter and is arranging for return of all recalled products. Wholesalers, retailers and consumers that are in possession of recalled product should contact Stericycle at 888-628-0727 for the return of the recalled product. Normal business hours are Monday through Friday 8 a.m. to 5 p.m. EST.
Consumers should contact their physician or healthcare provider if they have experienced any problems that may be related to using these drug products.
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.
Complete and submit the report Online
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.
Mylan is a global pharmaceutical company committed to setting new standards in healthcare. Working together around the world to provide 7 billion people access to high quality medicine, we innovate to satisfy unmet needs; make reliability and service excellence a habit; do what's right, not what's easy; and impact the future through passionate global leadership. We offer a growing portfolio of more than 7,500 marketed products around the world, including antiretroviral therapies on which approximately 40% of people being treated for HIV/AIDS globally depend. We market our products in more than 165 countries and territories. We are one of the world's largest producers of active pharmaceutical ingredients. Every member of our approximately 35,000strong workforce is dedicated to creating better health for a better world, one person at a time. Learn more at Mylan.com. We routinely post information that may be important to investors on our website at investor.mylan.com.
Mylan N.V .今天宣布，其位于美国的迈兰（Mylan） Pharmaceuticals 业务正在全国范围内自愿召回三批美国药典（包括150mg 和300mg 的强项）尼扎替丁胶囊（ Nizatidine Capsules ， USP ）。虽然迈兰（Mylan）至今尚未收到任何与这些批次相关的不良事件报告，但由于发现由 Solara Active Pharma Sciences Limited 生产的美国药典原料药（API） Nizatidine 中含有的杂质 N-亚硝基甲基胺（ NDMA ）微量，该产品被自动召回。
NDMA 是一种已知的环境污染物，存在于水和食品中，包括肉类、奶制品和蔬菜。根据国际癌症研究机构（ IARC ）的说法， NDMA 被列为可能的人类致癌物质（一种可能致癌的物质）。
产成品由迈兰（Mylan） Pharmaceuticals Inc .生产，该等批次于2017年6月至2018年8月间在全国范围内向批发商、邮购药店、零售药店、配送商进行配送。召回的批次情况如下：
尼扎替丁用于治疗活动性十二指肠溃疡和活动性良性胃溃疡的短期治疗（最多8周），作为十二指肠溃疡患者最多一年的维持治疗，以及最多12周用于治疗内镜诊断的食管炎和胃食管反流病（ GERD ）引起的相关胃灼。
迈兰（Mylan）正在通过信件通知其经销商和客户，并正在安排退回所有召回产品。拥有召回产品的批发商、零售商和消费者应致电888-628-0727与 Sterliccycle 联系，要求退回召回产品。正常工作时间是星期一至星期五上午8点至下午5点。
使用本产品过程中出现的不良反应或质量问题可通过常规邮件或传真在线向 FDA 的 MedWatch 不良事件报告程序报告。
这次召回是根据美国食品药品监督管理局（Food and Drug Administration）的知识进行的。
迈兰（Mylan）是一家致力于制定医疗保健新标准的全球性制药公司。在全球范围内共同努力，为70亿人提供高质量的药品，我们创新以满足未满足的需求；使可靠性和卓越的服务成为一种习惯；做正确的事，而不是容易的事；通过充满激情的全球领导影响未来。我们在全球提供超过7,500种市场营销产品，包括抗逆转录病毒疗法，全球约40%的艾滋病毒/艾滋病患者依赖抗逆转录病毒疗法。我们的产品销往165多个国家和地区。我们是世界上最大的原料药生产商之一。我们约35,000名员工中的每一位都致力于为一个更美好的世界创造更好的健康，一个人一次。在迈兰（Mylan）学习更多信息。com 。我们定期在投资者网站上发布对投资者可能重要的信息。米兰。com 。