China NMPA Drug Inspection - Chengdu Tiansheng Traditional Chinese Medicine Pieces Co., Ltd. - Mulberry bark
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On December 4, 2025, the National Medical Products Administration (NMPA) issued Announcement No. 43, identifying 35 batches of drugs from 29 companies that failed quality inspections. The testing, conducted by various provincial drug control institutes, identified significant issues across several product categories. Notable manufacturers listed include Sichuan Tongyuan Pharmaceutical Group, Jiangsu Wanbang Biochemical Pharmaceutical Group, and Sichuan Kelun Pharmaceutical. The primary violations involved critical quality parameters such as failed dissolution rates in acetaminophen tablets, the presence of visible foreign matter and insoluble particles in injections, and excessive impurities in eye drops. Furthermore, traditional Chinese medicine products from multiple firms showed physical property deviations and residues of organochlorine pesticides. Other non-compliance issues included failed microbial limits, incorrect pH levels, and insufficient biological activity in capsules. These findings were processed under the Drug Administration Law of the People's Republic of China. The NMPA has ordered the immediate suspension of sales and use for all affected products, alongside mandatory product recalls. The involved enterprises must investigate the causes of these failures and implement corrective actions. Provincial regulatory bodies are further tasked with investigating potential illegal conduct and publicly disclosing their findings.
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