China NMPA Drug Inspection - Shenyang Shenlong Pharmaceutical Co., Ltd. - Prostate Acute Retention Tablets

On October 22, 2020, the Chongqing Municipal Drug Administration released an announcement detailing quality failures for four batches of drugs produced by Shenyang Shenlong Pharmaceutical Co., Ltd., Harbin Sanmu Pharmaceutical Factory, Hengtuo Group Guangxi Shengkang Pharmaceutical Co., Ltd., and Shaanxi Ziguang Chenji Pharmaceutical Co., Ltd. The inspections, conducted by regional testing institutes, identified critical non-compliance issues involving prostate tablets, cough capsules, and traditional pills. The main violations centered on failed laboratory testing and physical appearance standards. Specifically, the regulators highlighted issues such as fill weight variation—which can result in inaccurate dosing and safety risks—and inconsistencies in the purity and concentration of active ingredients. These findings indicate potential instabilities in manufacturing processes or the use of sub-standard raw materials. The medications were evaluated under the regulatory framework of the Chinese Pharmacopoeia (2015 Edition), along with specific National and Ministry of Health drug standards. In response to these findings, the Chongqing Municipal Drug Administration has ordered immediate regulatory actions, including the sealing and seizing of stock, the suspension of sales, and the mandatory recall of the non-compliant batches. Local market supervision bureaus are tasked with overseeing these enforcement measures and handling the cases according to national laws to ensure public safety.