China NMPA Drug Inspection - Daigen Pharmaceutical Co., Ltd. - Cefotetan Hydrochloride for Injection

The National Medical Products Administration (NMPA) announced on December 28, 2018, that 18 batches of drugs from 14 companies were found to be non-compliant with regulations following testing by various drug inspection institutes. Key companies implicated include Jiangxi Jiulianshan Pharmaceutical, Heilongjiang Tianlong Pharmaceutical, Dayuan Pharmaceutical, Jilin Tonghua Boxiang Pharmaceutical, and several traditional Chinese medicine (TCM) producers such as Anguo Huifa. The primary violations spanned a range of quality control deficiencies. Heilongjiang Tianlong's tobramycin eye drops exhibited issues with preservatives. Dayuan Pharmaceutical's cefotetan hydrochloride for injection failed clarity and color specifications. Yunzhi Gantai granules from Jilin Tonghua Boxiang and Jiangxi Jiulianshan did not meet requirements for particle size, appearance, or content. Angelica dahurica products from multiple TCM companies failed content determination and showed excessive sulfur dioxide residue, while areca nuts from several other TCM firms were contaminated with aflatoxin. In response, the NMPA mandated immediate control measures, including sealing and seizing the affected products. Companies are required to suspend sales, recall the non-compliant batches, and implement corrective actions. Provincial drug regulatory authorities are tasked with investigating these enterprises for illegal activities, particularly regarding the production and sale of substandard drugs, under Articles 73, 74, and 75 of the "Drug Administration Law of the People's Republic of China." Investigations must be concluded and results publicly disclosed within three months.