China NMPA Product Recall - Pediatric antipyretic oral liquid; Weikangling capsules

The National Medical Products Administration (NMPA), formerly the State Food and Drug Administration, issued Announcement No. 104 of 2015 on December 23, 2015, regarding significant product non-compliance from Guangxi Rongren Pharmaceutical Co., Ltd. and Tonghua Limin Pharmaceutical Co., Ltd. During recent national drug sampling inspections, multiple batches of their products were found to be substandard.Guangxi Rongren Pharmaceutical Co., Ltd. was cited for ten batches of its children's antipyretic oral liquid failing content determination tests, with batch numbers spanning from August 2014 to July 2015. Concurrently, Tonghua Limin Pharmaceutical Co., Ltd. had three batches of its Weikangling capsules fail to meet regulatory standards due to excessive microbial limits, with batch numbers from 2014 and 2015. These findings reflect critical deficiencies in both companies' quality management systems.In response, the NMPA has mandated immediate and comprehensive recall measures for all affected products already on the market. Both companies are required to publicly disclose recall information and suspend production to undertake thorough rectification. This includes investigating the root causes of the quality issues and implementing effective corrective actions. Furthermore, provincial and local food and drug administrations are tasked with supervising these companies to ensure compliance and oversee the removal and sealing of non-compliant drugs from distribution and usage units. The NMPA committed to publicly releasing further relevant information.