Nagaich Upendra, Sadhna Divya
Department of Pharmaceutics, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India.
Department of Drug Regulatory Affairs, Amity Institute of Pharmacy, Amity University, Noida, Uttar Pradesh, India.
Int J Pharm Investig. 2015 Jan-Mar;5(1):13-9. doi: 10.4103/2230-973X.147222.
There has been an increasing trend in the number of prescribed and over-the-counter drug recall over the last few years. The recall is usually due to company's discovery, customer's complaint or Food and Drug Administration (FDA) observation. The process of recall involves a planned specific course of action, which addresses the depth of recall, need for public warning, and the extent of effectiveness checks for the recall. The FDA review and/or recommend changes to the firm's recall strategy, as appropriate. The critical recall information list includes the identity of the product; summary of the failure; amount of product produced in the distribution chain and direct account. Product recalls clashes thousands of companies every year affecting: sales, testing customer relationships and disrupting supply chains. Drug recall is incubus for pharmaceutical companies. It effects the reputation of the company. The reason for the recall can be divided into two categories: manufacturing affined and safety/efficacy affined. It is essential to follow all the guidelines related to drug development and manufacturing procedure so as to minimize drug recall.
在过去几年中，处方药和非处方药召回的数量呈上升趋势。召回通常是由于公司发现、客户投诉或食品药品监督管理局（FDA）的观察。召回过程涉及一个有计划的特定行动方案，该方案涉及召回的深度、公开警告的必要性以及召回有效性检查的范围。FDA会酌情审查和/或建议公司对召回策略进行更改。关键召回信息列表包括产品标识；故障摘要；分销链中生产的产品数量和直接账目。产品召回每年影响数千家公司，涉及：销售、测试客户关系和扰乱供应链。药品召回对制药公司来说是个梦魇。它影响公司的声誉。召回原因可分为两类：与生产相关的和与安全/疗效相关的。遵循所有与药物开发和生产程序相关的指导方针以尽量减少药品召回至关重要。
