China NMPA Drug Inspection - Changchun Puhua Pharmaceutical Co., Ltd. - Longze Bear Bile Capsules

In August 2022, the National Medical Products Administration (NMPA) issued Announcement No. 39, identifying 20 batches of drugs that failed to meet quality standards across several provinces. The non-compliant products were produced by nine pharmaceutical companies, including Zhengzhou Ruilong Pharmaceutical Co., Ltd., Shanxi Taiyuan Pharmaceutical Co., Ltd., Hebei Bianque Pharmaceutical Co., Ltd., and Guilin Zhongnan (Bozhou) Pharmaceutical Technology Co., Ltd.

The reported violations were diverse, ranging from safety hazards like visible foreign matter in injections and excessive methanol content in liquids to efficacy concerns such as poor content uniformity. Furthermore, several batches of traditional Chinese medicine components were found to contain prohibited pesticide residues, exceed microbial limits, or fail identification and purity tests (e.g., high ash content). These findings were confirmed through testing by multiple regulatory institutes, including the China National Institutes for Food and Drug Control.

Governed by the Drug Administration Law of the People's Republic of China, the NMPA has mandated immediate corrective actions. The involved enterprises are required to suspend the sale and use of all affected batches and initiate comprehensive product recalls. Additionally, the NMPA directed provincial authorities to conduct formal investigations into the root causes of these failures and pursue legal penalties for any suspected illegal activities. The companies must implement effective rectifications, and the results of the regulatory investigations will be made public to ensure transparency and consumer safety.