China NMPA Product Recall - Disposable medical masks

On July 28, 2020, Henan Shengyuan Medical Supplies Co., Ltd. initiated a voluntary Level III recall for a specific batch (No.: 200201) of its disposable medical masks. This action followed a notice from the Henan Provincial Drug Administration, which identified that the masks failed to meet bacterial filtration efficiency (BFE) regulations. The issue was initially flagged by the Changyuan City Drug Administration. The affected products were distributed within China, specifically in the Guangdong region. In response, the company promptly inspected its warehouse, directed a district hospital to immediately stop using the non-compliant batch, and successfully recalled the affected products. All recalled units are slated for destruction under the supervision of the drug administration, ensuring their removal from circulation. This recall highlights the regulatory framework enforced by the National Medical Products Administration (NMPA) and its provincial authorities, underscoring the commitment to product safety and adherence to quality standards in medical supplies.