China NMPA Product Recall - Sodium fusidate for injection (Lisidin)

Leo Pharmaceutical Products Ltd. (LEO A/S), through its entrusted entity Invida International Trading (Shanghai) Co., Ltd., initiated a voluntary recall of Fusidic Acid Sodium for Injection (trade name: Lisidin) from the Chinese market. The National Medical Products Administration (NMPA) received the recall report on July 26, 2010. The primary reason for the recall is the discovery of glass fragments inside the glass vials of Lisidin, specifically identified in batches DD8874, DD9936, and DE4117. To ensure patient safety and mitigate potential risks, LEO A/S decided to recall all batches of the product, including but not limited to DB8710, DC1348, and DE4117. This action was taken in accordance with relevant regulatory provisions, such as the "Recall Management Measures." No adverse drug events resulting from this quality complaint have been reported. Invida International Trading (Shanghai) Co., Ltd. is responsible for closely monitoring the recall process and providing updates to the drug regulatory authorities.