China NMPA Product Recall - Nasal spray

Guangyu Pharmaceutical Technology (Ningxia) Co., Ltd. has initiated a Class III voluntary recall of specific batches of its nasal sprays, publicly announced by the National Medical Products Administration (NMPA) on January 16, 2020. This measure was prompted by findings from an NMPA unannounced inspection, which identified that the company had not consistently adhered to its established finished product inspection procedures. Specifically, the company failed to conduct required monthly outsourced microbial limit testing for several product batches. The recall impacts batches including 20190501, 20190701, 20190702, 20190801, 20190802, and 20190901, distributed within China. As part of its corrective actions, Guangyu Pharmaceutical Technology issued a formal recall notice for these batches. The company also undertook external testing of retained samples from the affected production runs, confirming that these samples met all microbial limit specifications. Further actions include continued risk assessments to ensure product safety and implementing necessary risk control measures, with the company committing to replace all recalled products. This incident highlights the NMPA's role in enforcing manufacturing quality standards and the importance of consistent compliance with internal and regulatory quality control requirements.