What procedure should a wholesaler follow if a batch of medicines needs to be recalled? What key steps should the SOP include?

A medicine recall is a key risk response within the quality management system and requires a rapid, accurate and efficient response. Once you receive a recall notification from a manufacturer or regulatory authority, or discover a serious product quality problem yourself, you must immediately initiate the recall procedure. Your recall SOP should clearly define different recall classes (such as Class I, II and III) and specify the response time and action plan for each. Key steps include: 1. Immediately quarantine affected batches and stop their distribution; 2. promptly identify all customers who purchased the batches and the quantities distributed; 3. issue written recall notices to all relevant customers within the prescribed time; 4. arrange the return, receipt, segregation and handling of recalled medicines; 5. continuously monitor recall progress and report regularly to the manufacturer and Department of Health; 6. investigate the root cause and take corrective and preventive action (CAPA).