China NMPA Drug Inspection - Hebei Linshi Shengtai Pharmaceutical Co., Ltd. - betel nut

The National Medical Products Administration (NMPA) of China released Announcement No. 110 on November 2, 2018, disclosing that 47 batches of drugs from 23 manufacturers failed to meet regulatory standards. This followed testing by various national and provincial drug control institutes. Significant issues identified include Taicang Pharmaceutical Factory's Doxepin Hydrochloride Tablets (24 batches), which failed for weight variation, indicating inconsistent dosage. Eleven batches of areca nuts, from companies such as Hebei Liankang Pharmaceutical and Sichuan Provincial Traditional Chinese Medicine Pieces Co., Ltd., were found to have unacceptable moisture content and aflatoxin levels, raising purity and safety concerns. Additionally, ten batches of chicken gizzard lining products from manufacturers like Anguo Juyitang Pharmaceutical and Shanghai Wanshicheng Pharmaceutical were non-compliant regarding extractives. Anhui Tongtai Pharmaceutical Co., Ltd.'s Ganoderma lucidum capsules (one batch) exceeded microbial limits, and Shanxi Wanhui Pharmaceutical Co., Ltd.'s Qingwei Huanglian Pills (one batch) exhibited failures in identification and fill weight uniformity. These violations underscore deficiencies in product quality, manufacturing control, and adherence to purity and consistency standards, as defined by the Chinese Pharmacopoeia and other relevant drug standards. The NMPA has mandated control measures including sealing, seizing, sales suspension, product recalls, and corrective actions by the involved enterprises. Provincial regulatory authorities are required to investigate these companies under Articles 73, 74, and 75 of the Drug Administration Law of the People's Republic of China for producing and selling substandard drugs, with results to be publicized within three months.