China NMPA Drug Inspection - Gansu Tiansen Pharmaceutical Co., Ltd. - Oxytetracycline tablets

On January 26, 2017, China's State Administration for Market Regulation (formerly SFDA) announced findings of 14 batches of substandard drugs from ten pharmaceutical companies, following tests by six drug testing institutions. Companies implicated included Fuzhou Haiwang Fuyao Pharmaceutical Co., Ltd., Guangxi Yulin Fangte Pharmaceutical Co., Ltd., Henan Wandong Pharmaceutical Co., Ltd., Shanghai Xinyi Pharmaceutical Co., Ltd., Hengtuo Group Rensheng Pharmaceutical Co., Ltd., and others. The substandard products ranged from Alanylglutamine injection to various tablets, capsules, and syrups. The main quality control issues involved failures in content determination, tests for ammonia, related substances, total aerobic bacteria count, fill weight variation, moisture content, disintegration time, and weight variation. Provincial food and drug administrations were immediately instructed to implement control measures, including sealing and seizing the affected drugs, suspending sales and usage, and initiating recalls. Operating under the 'Drug Administration Law of the People's Republic of China' and relevant regulations, manufacturers are required to thoroughly investigate the causes, implement comprehensive rectifications, and promptly disclose information. Authorities are also tasked with investigating these companies and handling cases according to law.