China NMPA Drug Inspection - The label indicates 14 manufacturers (preparation units). - 14 varieties (15 batches of drugs in total)

The Shandong Provincial Drug Administration issued Announcement No. 8 of 2020, detailing the results of supervisory sampling inspections conducted in May 2020. The inspections identified 15 batches of non-compliant drugs from 14 different manufacturers and preparation units across the production, distribution, and healthcare sectors. The findings, published on June 3, 2020, highlight significant deviations from pharmaceutical standards intended to ensure public safety and medication efficacy. Key violations identified include failures in physical properties, such as improper appearance and species deviations in herbal materials. Other critical issues involved insufficient fill weights, high total ash content indicating impurity, and inaccuracies in active ingredient potency. Furthermore, several products failed tests for dissolution rates and disintegration time, which negatively impact drug absorption and therapeutic effectiveness. Microbial limit violations were also noted, raising concerns about potential contamination. Operating under the regulatory framework of the National Medical Products Administration (NMPA) and provincial drug laws, the administration has initiated immediate enforcement actions. These include the seizure, sealing, and recall of the affected batches, as well as the suspension of sales. The involved companies face severe administrative penalties. To prevent future occurrences, the regulatory body has mandated that manufacturers conduct thorough root-cause investigations, implement corrective actions, and strictly monitor production processes to eliminate potential risks to public health.