State Drug Administration notice: a batch of drugs suspended sales, recall.

On July 23, the State Drug Administration issued a "Notice on 25 batches of drugs that do not comply with the regulations (No. 50 of 2020)" (hereinafter referred to as "Notice").
notice shows that by the Henan Province Food and Drug Inspection Institute and other 9 drug inspection institutions, marked as Jiangsu Wu Chinese Medicine Group Co., Ltd. Suzhou Pharmaceutical Factory and other 14 pharmaceutical manufacturers produced 25 batches of drugs do not meet the requirements.
notice that, for the above non-compliant drugs, the drug regulatory department has asked the relevant enterprises and units to take the suspension of sales use, recall and other risk control measures, the reasons for non-compliance to investigate and effectively carry out rectification.
at the same time, the State Drug Administration requires the relevant provincial drug regulatory departments to organize investigations into the illegal acts of the above-mentioned enterprises and units in the production and sale of counterfeit and inferior drugs in accordance with the Drug Administration Law of the People's Republic of China, and to publicly investigate and investigate the results in accordance with the provisions.
as follows: by the Henan Province Food and Drug Inspection Institute inspection, marked as Jiangsu Wu Chinese Medicine Group Co., Ltd. Suzhou Pharmaceutical Factory produced 9 batches of injection of amika star sulfate non-compliance with the provisions, non-compliance with the provisions of the project for the clarity of the solution and color.
by the Guangxi Zhuang Autonomous Region Food and Drug Inspection Institute, marked as Anhui Guozheng Pharmaceutical Co., Ltd. produced a batch of compound-based xylitol potassium sulfonate oral solution does not comply with the provisions, non-compliance with the provisions of the item for loading.
by the Jiangsu Province Food and Drug Supervision and Inspection Research Institute inspection, marked as Hunan Warner Big Pharmaceutical Co., Ltd. produced a batch of Lansora intestinal tablets do not comply with the regulations, non-compliance with the provisions of the project for the dissolving degree.
by the Shanghai Food and Drug Inspection Institute, marked as Hainan General Kangli Pharmaceutical Co., Ltd. produced 4 batches of injection with Ozagray sodium does not comply with the regulations, non-compliance with the provisions of the project is visible foreign matter.
by the Hubei Province Drug Supervision and Inspection Research Institute inspection, marked as Changchun People's Pharmaceutical Group Co., Ltd. produced a batch of infant spleen scattered non-compliance with the provisions, non-compliance with the provisions of the item for the granularity.
by the Sichuan Food and Drug Inspection and Inspection Institute inspection, marked as Jiangxi Hongshuo Pharmaceutical Co., Ltd. produced 1 batch of Yuanhu painkillers do not comply with the provisions, non-compliance with the provisions of the item for content determination;
by the China Food and Drug Inspection Research Institute inspection, marked as Hebei Jixin Tang Pharmaceutical Co., Ltd. produced 1 batch of broad fennel incense does not comply with the regulations, does not meet the provisions of the item is a characteristic.
by the Anhui Province Food and Drug Inspection Research Institute inspection, marked as Chongqing Sanlitang Chinese Medicine Pharmaceutical Co., Ltd., Chengdu Ji'ankang Pharmaceutical Co., Ltd., Neijiang Lianghui Pharmaceutical Co., Ltd. production of 3 batches of yellow essence does not meet the provisions, does not meet the provisions of the project as a characteristic.
by the Dalian City Drug Inspection and Inspection Institute inspection, marked as Xinjiang Herb Hall Pharmaceutical Co., Ltd. produced a batch of pre-Hu non-compliance with the provisions, non-compliance with the provisions of the item as a characteristic.
by the China Food and Drug Inspection Research Institute inspection, marked as Chengdu Yulong Chinese medicine tablets Co. , Ltd. produced a batch of Sichuan Wu non-compliance with the regulations, non-compliance with the provisions of the item as a characteristic.
attached: non-compliance with the provisions of the small knowledge of one, the clarity of the solution is to compare the drug solution with the prescribed turbidity standard liquid, to check the degree of clarification of the solution; the clarity and color of the
solution can reflect the purity of the drug to some extent, and it is a method that can carry out the drug quality check quickly, easily and accurately.
, the loading system reflects the weight or capacity of drugs indicators, applicable to solid, semi-solid, liquid preparations, the provisions should be in accordance with the minimum load inspection method for inspection, non-compliance with the provisions will lead to insufficient clinical dose.
3, solubility refers to the rate and degree of the dissolution of the active drug from the formulation, non-compliance will affect the absorption of the drug, reduce the degree of biological utilization.
4. Visible foreign body refers to the insoluble substance that is present in injection sints, eye liquid preparations, and can be observed under the prescribed visual conditions, and its particle size or length is usually greater than 50 microns.
V. The particle size is the size of the particles, the drug has the particle size requirements of the preparation products such as granules, dispersants, mixed suspension eye drops, mixed suspension ointment, etc. will carry out the setting of the project, non-compliance may lead to the main component of the drug content is uneven.
, content determination refers to the use of prescribed test methods to determine the content of the active ingredients in raw materials and preparations, generally by chemical, instrument or biometric methods.
7, gold amine O is a pigment or dye, detected the ingredient, indicating that there is dyeing phenomenon.
eight, the characteristics of the recorded appearance, odor, taste, solubility and physical constants, to a certain extent, reflect the quality characteristics of drugs.
chinese medicine drink tablets does not comply with the provisions, may involve the deviation of the genus of the medicinal material, the preparation process is defective, improper storage and other circumstances.
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