China NMPA Drug Inspection - Guangdong Yifang Pharmaceutical Co., Ltd - Promethazine Hydrochloride Injection

The Henan Provincial Food and Drug Administration in China issued a drug quality announcement on January 17, 2017, detailing findings from supervisory sampling inspections. These inspections were conducted to enhance drug quality oversight and protect public health within Henan Province. The announcement identified 46 batches of drugs that failed to meet established quality standards, originating from numerous manufacturers and dispensed at various pharmacies and hospitals.

Significant violations included the identification of counterfeit Atorvastatin Calcium Tablets attributed to Pfizer Pharmaceutical Co., Ltd. Other widespread issues spanned multiple product types, from injectable medications to Traditional Chinese Medicine (TCM) ingredients. Common deficiencies included the presence of visible foreign matter, deviations in product appearance, failures in identification and chromatographic tests, and non-compliance with specifications for moisture content, relative density, total ash, acid-insoluble ash, and active ingredient determination. Companies such as Guangdong Nanguo Pharmaceutical Co., Ltd., Jiangxi Pharmaceutical Co., Ltd., and several local TCM producers were among those whose products were found substandard.

All localities are mandated to investigate and address these violations in accordance with the "Drug Administration Law of the People's Republic of China" and other pertinent regulations. The required actions involve enforcement measures against the non-compliant entities to ensure public medication safety and uphold drug quality standards.