China NMPA Drug Inspection - Jilin Tonghua Boxiang Pharmaceutical Co., Ltd. - Cold and flu soft capsules (batch number 190101)

The Hebei Provincial Drug Administration issued its first 2020 quality bulletin on March 31, following inspections conducted under the provincial drug supervision and sampling plan. The report details quality failures across several pharmaceutical entities, including Jilin Tonghua Boxiang Pharmaceutical Co., Ltd., Anguo Shenghe Pharmaceutical Co., Ltd., Hebei Renxin Pharmaceutical Co., Ltd., Jiuquan Peifeng Traditional Chinese Medicine Ecological Planting and Processing Co., Ltd., and Anguo Yuanguang Pharmaceutical Co., Ltd. Main violations centered on structural and physical non-compliance. Specifically, cold soft capsules failed disintegration requirements, while various traditional Chinese medicine products, such as Angelica sinensis and Trichosanthes kirilowii, were found to be infested with insects. These failures represent significant deviations from required safety and efficacy standards. Regulated under the Drug Administration Law of the People's Republic of China, authorities have already implemented control measures, including the sealing and seizure of defective batches. The administration has ordered formal investigations and prosecutions of the manufacturers and distributors involved. Required actions include mandatory risk control measures and a public reporting of case resolutions within three months. Any findings of counterfeit products or potential criminal activity must be referred to public security departments for further prosecution.