Core Viewpoint - Enhua Pharmaceutical has initiated a Class III recall of the Carbamates Tartrate Capsules due to quality management issues identified during an inspection of the manufacturing facility by the National Medical Products Administration (NMPA) [1][2]. Group 1: Recall Details - The recall involves Carbamates Tartrate Capsules, which are used to treat mild to moderate Alzheimer's disease [2]. - The recall is classified as Class III, indicating that while it generally does not pose a health risk, it is necessary for other reasons [2]. - Enhua Pharmaceutical stated that the recall is in compliance with the relevant regulations to ensure medication safety [2]. Group 2: Financial Impact - In 2025, the sales revenue from the recalled product was approximately 40 million yuan, accounting for less than 1% of the company's total revenue [2]. - The estimated sales amount involved in the recall is around 9 million yuan, with the actual quantity and amount of recalled products yet to be determined [2]. - The company plans to reduce its current operating income by the sales amount of the recalled products, which is expected to have a minimal impact on overall revenue [3]. Group 3: Future Measures - Enhua Pharmaceutical intends to strengthen supplier management and improve its quality management system to ensure product quality and patient safety in the future [3].
恩华药业子公司启动三级药品召回