China NMPA Drug Inspection - Emeishan Tonghui Pharmaceutical Co., Ltd. - Azithromycin for Injection

The Jiangsu Provincial Drug Administration released a public announcement on December 1, 2021, detailing the results of its third drug quality inspection batch for the year. The report identified 13 batches of non-compliant pharmaceutical products found across various regional production, distribution, and healthcare units. Key entities involved in the violations include Anhui Huadingtang Traditional Chinese Medicine Pieces Technology Co., Ltd., Anhui Pujian Traditional Chinese Medicine Pieces Co., Ltd., and Emeishan Tonghui Pharmaceutical Co., Ltd. The main quality issues identified were physical appearance discrepancies, improper processing of traditional medicines, and excessive microbial levels in capsules. Notably, five batches—including samples of Pueraria lobata and Myrrh—were confirmed as counterfeit, while certain injectable antibiotics failed standards for solution clarity and color. These inspections were conducted under the regulatory framework of the Chinese Pharmacopoeia (2015 and 2020 editions) and National Drug Standards. In response, the administration has ordered all involved enterprises to immediately suspend the sale and use of these batches and implement strict risk control measures. Furthermore, the companies must investigate the causes of these failures, execute corrective actions, and undergo formal administrative investigations and potential legal penalties to ensure future compliance.