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

On December 1, 2021, the Jiangsu Provincial Drug Administration released findings from its third annual sampling inspection, identifying 13 batches of non-compliant pharmaceutical products. The inspection covered various production, distribution, and healthcare units. Labeled manufacturers cited for violations include Anhui Huadingtang, Jiangsu Zhongyu Pharmaceutical, Anhui Pujian Traditional Chinese Medicine Pieces, and Emeishan Tonghui Pharmaceutical. The primary issues discovered during testing involved failures in physical appearance, processing methods, and chemical solution clarity. Notably, five batches—including Pueraria lobata and Vinegar Myrrh—were confirmed as counterfeit. Other significant violations included Gastrodia elata capsules failing microbial limit tests for aerobic bacteria and Azithromycin for Injection failing standards for solution color and transparency. These assessments were based on the regulatory standards of the Chinese Pharmacopoeia (2015 and 2020 editions). Following these findings, the Jiangsu drug regulatory departments have ordered the immediate suspension of sales and use for all affected batches. The implicated companies are required to investigate the source of these quality failures, implement corrective actions, and undergo formal legal proceedings and penalties as mandated by provincial law.