China NMPA Product Recall - Medical surgical masks

Henan Kanghua Pharmaceutical Co., Ltd. initiated a voluntary Level III recall of 96,000 units of its medical surgical masks. This action, reported to the National Medical Products Administration (NMPA) on November 28, 2020, followed provincial sampling inspections around June 6, 2020, which revealed that a batch of these masks failed to meet sterility requirements. The affected product, registered under code 豫械注准20202140178, is designed for clinical use to protect against pathogenic microorganisms and body fluids. The non-compliance with sterility standards posed a potential risk in healthcare settings. In response, Henan Kanghua Pharmaceutical Co., Ltd. sent recall notices to customers and developed a recall plan to retrieve the non-compliant masks. The company also committed to cooperating with ongoing investigations and accepting further directives from drug regulatory authorities to ensure product quality and public safety, under the oversight of the NMPA and provincial food and drug administration departments.