When should a medicine recall be initiated, and what is the specific procedure?

A medicine recall is an urgent measure taken to protect public health when a quality, safety or efficacy problem is found in a medicine already on the market. Circumstances requiring a recall include contamination, incorrect labelling, packaging defects, incorrect active ingredient content and failed stability tests. Once a recall is deemed necessary, the licensed manufacturer or wholesaler must immediately notify the Department of Health and initiate its internal recall procedure. The general process is: 1. Risk assessment: determine the seriousness of the issue and its potential scope, and define the recall level (for example, recall to the doctor/pharmacy level or to the consumer level). 2. Notification and communication: submit a detailed recall plan to the Department of Health and promptly notify all affected downstream customers, such as other wholesalers, hospitals and pharmacies. 3. Recall execution: arrange logistics to retrieve all affected batches and segregate them in storage. 4. Investigation and reporting: thoroughly investigate the root cause, take corrective and preventive action (CAPA), and submit the final recall and investigation reports to the Department of Health.