China NMPA Drug Inspection - Shanghai Modern Hasen (Shangqiu) Pharmaceutical Co., Ltd. - Phenytasol tablets

The Hubei Province Drug Administration released findings from its First Round of Drug Sampling Inspections conducted in 2018, revealing 107 batches of non-compliant drugs. These issues impacted numerous manufacturers and dispensing units province-wide. Key violations included deviations from quality standards, such as incorrect moisture content, inaccurate active ingredient concentrations, and a lack of content uniformity in both finished drug products and Traditional Chinese Medicine (TCM) pieces. Additionally, contaminants like aflatoxin and heavy metals (e.g., lead, arsenic) were detected, and some pharmaceutical packaging materials showed elevated residual solvent levels. Notably, several identified manufacturers denied producing certain non-compliant batches, indicating potential supply chain integrity issues. Operating under the "Drug Administration Law of the People's Republic of China" and specific drug quality standards, the Hubei Provincial Food and Drug Administration mandated swift and stringent actions. Local authorities are required to investigate all implicated parties, report comprehensive findings to the Provincial Bureau, and meticulously trace the origins of drugs from unverified sources. Cases where criminal activity is suspected must be promptly transferred to public security authorities for legal prosecution, emphasizing the agency's commitment to public health and regulatory enforcement.