China NMPA Drug Inspection - Hefei Jiulian Pharmaceutical Co., Ltd. - Compound diphenoxylate tablets

The Henan Provincial Food and Drug Administration issued a Drug Quality Announcement on July 31, 2013, detailing the results of comprehensive drug quality sampling inspections conducted across the province in the second half of 2012. These inspections, guided by the '2012 Henan Province Drug Quality Supervision and Sampling Inspection Work Plan,' aimed to reinforce drug quality oversight and ensure public safety.

Inspections encompassed both essential medicines and routine drug supervision. Out of 2,585 batches of essential medicines sampled, four were found to be substandard. In the routine drug supervision category, 14 out of 8,834 batches were identified as substandard. Several manufacturers, including Yabao Pharmaceutical Group, Changchun Dirui Pharmaceutical, Shandong Xinhua Pharmaceutical, Jinan Yongning Pharmaceutical, Jilin Tonghua Boxiang Pharmaceutical, and Shanxi Fenhe Pharmaceutical, were implicated. Violations primarily involved failures in content uniformity, dissolution, content determination, identification (such as HPLC or liquid chromatography), weight difference, pH value, properties, visible foreign matter, and solubility. One instance of counterfeit product was reported. The inspections adhered to standards from the Chinese Pharmacopoeia 2010 Edition, State Food and Drug Administration National Drug Standards, and Ministry of Health Drug Standards. Consequently, municipal food and drug administrations were directed to investigate and address these substandard drugs and the involved entities, submitting their findings to the provincial administration by August 30, 2013.