China NMPA Drug Inspection - Shandong Fangming Pharmaceutical Group Co., Ltd. - Ethylphenidyl sulfonamide injection

The Jiangxi Provincial Drug Administration issued its 5th Drug Supervision and Sampling Information Announcement of 2019 on December 17, 2019, detailing the results of inspections conducted across drug production, operation, and use units. These inspections, guided by China's Drug Administration Law and provincial sampling plans, aimed to bolster drug quality and public safety.

The announcement revealed that 173 batches across 80 drug varieties failed to meet established standards. For injectable drugs, a prevalent issue was the presence of "visible foreign matter," affecting products like Concentrated Sodium Chloride Injection from Shanghai Xudong Haipu Pharmaceutical, Dexamethasone Sodium Phosphate Injection from Tianjin Jinyao Group Hubei Tianyao Pharmaceutical, and Inosine Injection from Shanghai Modern Hasen (Shangqiu) Pharmaceutical. Traditional Chinese Medicine (TCM) pieces, from manufacturers such as Jiangxi Hongjie Traditional Chinese Medicine Pieces Co., Ltd. and Jiangxi Zhaosheng Traditional Chinese Medicine Pieces Co., Ltd., frequently showed non-compliance in "appearance," "identification," and "content determination," along with issues like excessive moisture, total ash, heavy metals, and sulfur dioxide residues. The primary regulatory frameworks for these inspections included the Chinese Pharmacopoeia (various editions) and specific National Drug Standards or provincial processing standards.

In response to these findings, the Jiangxi Provincial Drug Administration has directed immediate control measures, including the sealing, seizure, suspension of sales, and recall of the substandard drugs. Furthermore, comprehensive investigations and penalties against the responsible manufacturers and sampled units are being pursued to ensure strict adherence to regulatory requirements.