Ensuring the safety, efficacy and quality of pharmaceutical products is a prime responsibility of the manufacturers and distributors (e.g., Importers) of medicines. The responsibility is shared with the Ethiopian Food Medicine and Healthcare Administration and Control Authority (EFMHACA).When pharmaceutical products are suspected of being potentially harmful to users due to their defective quality, safety or efficacy, they may be subjected to a recall and all related information must be report to Food, Medicine and Healthcare Administration and Control Authority (EFMHACA) of Ethiopia. These Guidelines are recognized as being appropriate to the specialized requirements for the recall of pharmaceutical products and are the licensing conditions for all licenses issued by EFMHACA. For any Licensee that has failed to comply with those conditions, EFMHACA may revoke or suspend the license for a period of time that it believes appropriate. The role of EFMHACA in a recall is to assess the adequacy of the Licensee’s decision on the recall of the product and, should action be taken, to monitor the progress and effectiveness of the recall. EFMHACA may alert the public of the problem with the specified product and instruct the Licensee to recall and dispose of the product according to the circumstances. The recall might be initiated by the manufacturer, wholesaler or license holder, or by EFMHACA. Ensuring the safety, efficacy and quality of pharmaceutical products is a prime responsibility of the manufacturers and distributors (e.g., Importers) of medicines. The responsibility is shared with the Ethiopian Food Medicine and Healthcare Administration and Control Authority (EFMHACA).When pharmaceutical products are suspected of being potentially harmful to users due to their defective quality, safety or efficacy, they may be subjected to a recall and all related information must be report to Food, Medicine and Healthcare Administration and Control Authority (EFMHACA) of Ethiopia. These Guidelines are recognized as being appropriate to the specialized requirements for the recall of pharmaceutical products and are the licensing conditions for all licenses issued by EFMHACA. For any Licensee that has failed to comply with those conditions, EFMHACA may revoke or suspend the license for a period of time that it believes appropriate. The role of EFMHACA in a recall is to assess the adequacy of the Licensee’s decision on the recall of the product and, should action be taken, to monitor the progress and effectiveness of the recall. EFMHACA may alert the public of the problem with the specified product and instruct the Licensee to recall and dispose of the product according to the circumstances. The recall might be initiated by the manufacturer, wholesaler or license holder, or by EFMHACA. These Guidelines are recognized as being appropriate to the specialized requirements for the recall of pharmaceutical products and are the licensing conditions for all licenses issue