China NMPA Drug Inspection - Tianjin Jinyao Group Hubei Tianyao Pharmaceutical Co., Ltd. - Dexamethasone sodium phosphate injection
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The Heilongjiang Provincial Food and Drug Administration (FDA) issued an announcement on June 8, 2018, detailing findings from tests conducted by five institutions on nine batches of substandard drugs. Key issues involved multiple pharmaceutical companies and their products. Henan Jinhongtang Pharmaceutical Co., Ltd. (Shujin Huoxue Tablets), Tianjin Jinyao Group Hubei Tianyao Pharmaceutical Co., Ltd. (Dexamethasone Sodium Phosphate Injection), and Heilongjiang Xiangtai Traditional Chinese Medicine Pieces Co., Ltd. (Ziziphus Jujuba Seed (fried)) had products failing general inspection and appearance criteria. A further six batches, including Poria cocos from Bozhou Traditional Chinese Medicine Pieces Factory and Compound Glycyrrhiza Tablets from Guangxi Guilin Nanfang Pharmaceutical Co., Ltd., failed appearance and identification tests. Critically, these six batches were confirmed not to have been produced by their labeled manufacturers, indicating significant mislabeling or potential counterfeiting. Pursuant to Articles 73, 74, and 75 of the *Drug Administration Law of the People's Republic of China*, regulatory bodies mandated immediate actions. Local food and drug administrations were instructed to implement control measures such as sealing and seizing affected products, requiring units to cease sales and usage. Furthermore, departments must investigate and prosecute illegal activities, referring criminal cases to public security departments. Resolution outcomes must be publicized within three months and reported to the Provincial Bureau, reinforcing stringent oversight on drug quality and safety.
ID · 507dd0da-7f65-4bf9-b5fa-a12e020c8cd7