China NMPA Drug Inspection - Jilin Tonghua Boxiang Pharmaceutical Co., Ltd. - Hepatitis B Detoxification Capsules

The National Medical Products Administration (NMPA) announced on October 19, 2018, that 19 batches of drugs from 17 companies, including Suzhou Hongsen Pharmaceutical Co., Ltd., Hebei Chuangjian Pharmaceutical Co., Ltd., and Jilin Tonghua Boxiang Pharmaceutical Co., Ltd., were found to be non-compliant. Inspections conducted by six drug testing institutions identified various quality deficiencies. Major violations included incorrect content determination for drugs like Doxepin Hydrochloride Tablets and Angelica pubescens, improper fill volume in Olopatadine Hydrochloride Eye Drops, and the presence of visible foreign matter in Paclitaxel Injection. Additionally, several traditional Chinese medicine products, such as Areca Nut and Angelica pubescens, contained excessive aflatoxin, moisture, or sulfur dioxide residue. Regulatory actions, based on Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China, included immediate control measures like sealing and seizing the products. The involved companies were instructed to suspend sales and use, recall affected batches, and implement corrective actions. Provincial drug regulatory authorities were mandated to investigate the non-compliant companies and publicly disclose their findings within three months.