China NMPA Drug Inspection - Huazhong Pharmaceutical Co., Ltd - Dexamethasone sodium phosphate injection

On September 26, 2019, the National Medical Products Administration (NMPA) announced findings from drug quality tests, identifying seven batches of non-compliant drugs from four pharmaceutical companies. Harbin Tianmu Pharmaceutical Co., Ltd. had one batch of Calcium Gluconate Oral Solution with an incorrect fill volume. Huazhong Pharmaceutical Co., Ltd. and Zhengzhou Zhuofeng Pharmaceutical Co., Ltd. each had batches of Dexamethasone Sodium Phosphate Injection containing visible foreign matter. Luoyang Tiansheng Pharmaceutical Co., Ltd. was cited for four batches of Lumbar Pain Tablets found to contain rosin acid, indicating potential raw material adulteration. These violations were identified against standards such as the Pharmacopoeia of the People's Republic of China and NMPA regulations. The NMPA mandated immediate risk control measures for the implicated companies, including suspending sales, recalling affected products, investigating root causes, and implementing corrective actions. Furthermore, provincial drug regulatory authorities were directed to conduct investigations into these illegal production and sales activities under the Drug Administration Law of the People's Republic of China. These investigations must conclude and their results be publicized within three months, emphasizing the strict regulatory oversight and commitment to drug safety in China.