The State Food and Drug Administration issued a notice today. After inspection by 10 drug inspection agencies including the Hubei Provincial Institute of Drug Supervision and Inspection, was labeled as acetylcysteine injection produced by Ruiyang Pharmaceutical Co., Ltd. and other 16 companies. 19 batches of medicines did not meet the regulations.
Screenshot of the official website of the State Food and Drug Administration
According to the notice, after inspection by the Liaoning Provincial Drug Inspection and Testing Institute, it was marked as 1 batch of based on erythromycin granules produced by Shanghai Diran Dancheng Pharmaceutical Co., Ltd. did not comply with the regulations , did not comply The specified item is content determination.
After inspection by the Hubei Provincial Institute of Drug Supervision and Inspection, two batches of acetylcysteine injection produced by Ruiyang Pharmaceutical Co., Ltd. labeled as did not meet the regulations , and the non-compliant items were hydrogen sulfide . It is reported that the sulfhydryl group in acetylcysteine in the hydrogen sulfide solution state (the pharmacodynamic effect of acetylcysteine relies on its sulfhydryl group to break the disulfide bond in the glycoprotein polypeptide chain in sputum) ) forms unstable detachment when the temperature rises and is irritating to the respiratory system.
After inspection by the Guangdong Provincial Institute for Drug Control, two batches of Longze Bear Bile Capsules produced by Tonghua Zhongsheng Pharmaceutical Co., Ltd. marked as did not meet the regulations . The non-compliance items were properties and disintegration time .
It is reported that the appearance, odor, taste, solubility and physical constants are recorded under the characteristics, which reflect the quality characteristics of the drug to a certain extent. The properties of traditional Chinese medicine pieces that do not meet the regulations may involve deviations in the species of medicinal materials, defects in the processing technology, improper storage, etc.; the disintegration time refers to the disintegration of oral solid preparations under specified conditions. For preparations that require the inspection of dissolution , release, melting time or dispersion uniformity, the disintegration time limit will no longer be inspected.
After inspection by the Shandong Provincial Food and Drug Inspection Institute, it was marked as One batch of Ginseng Jianpi Pills produced by Tianjin Zhongxin Pharmaceutical Group Co., Ltd. Darentang Pharmaceutical Factory did not meet the regulations , and the items that did not meet the regulations were Loading volume difference.
After inspection by the Tibet Autonomous Region Food and Drug Inspection Institute, a batch of fifteen-flavor black pills produced by Tibet Qamdo Tibetan Medicine Factory, labeled as , did not meet the regulations . The non-compliance items were weight difference and microbiological limits.
It is reported that microbial limits are microbial control requirements for pharmaceutical preparations that do not directly enter the human body environment. Since the medication risk of such pharmaceutical preparations is slightly lower, a certain number of microorganisms can be allowed to exist, but some conditional pathogenic bacteria must not be detected. Microbial limits are divided into two parts: counting inspection and control bacteria inspection.
was inspected by the Henan Provincial Food and Drug Inspection Institute and marked as Harbin Songshantang Pharmaceutical Co., Ltd. , Sichuan Jiuweige Traditional Chinese Medicine Pieces Co., Ltd. produced two batches of mugwort leaves that did not meet the regulations , and the items that did not meet the regulations were all content Determination.
was inspected by the Sichuan Provincial Institute for Drug Control (Sichuan Provincial Medical Device Testing Center) and was marked as . One batch of produced by Hubei Mintai Pharmaceutical Co., Ltd. did not comply with the regulations . The non-compliant items were Traits.
was inspected by China Institute of Food and Drug Control and marked as Jiangsu Donglian Pharmaceutical Co., Ltd. , Anhui Wansheng Traditional Chinese Medicine Pieces Co., Ltd. , 3 batches produced by Hunan Songlingtang Traditional Chinese Medicine Pieces Co., Ltd. Chrysanthemum does not comply with the regulations of , and the items that do not comply with the regulations are all banned pesticide residues.
was inspected by the Gansu Provincial Institute for Drug Control and marked as Guangzhou Weida Traditional Chinese Medicine Pieces Co., Ltd. , Sichuan Yuanshangcao Traditional Chinese Medicine Pieces Co., Ltd. , and 4 batches of madder produced by Sichuan Yunbotang Pharmaceutical Co., Ltd. Non-compliance with regulations , non-compliance with regulations includes properties, microscopic identification, and leachables; marked as A batch of madder (Rudera charcoal) produced by Sichuan Xinkang Traditional Chinese Medicine Pieces Co., Ltd. does not comply with regulations, and non-compliance with regulations includes properties. .
After inspection by the Anhui Provincial Food and Drug Inspection Institute, a batch of peach kernels produced by Zhangshu Qingren Traditional Chinese Medicine Pieces Co., Ltd. labeled as did not meet the regulations , and the non-compliance item was the carbonyl value. It is reported that the carbonyl value reflects the amount of carbonyl-containing compounds and other substances that are produced when oil-containing Chinese medicinal materials and pieces become rancid, which may be related to improper storage.
The State Food and Drug Administration stated that for the above-mentioned non-compliant drugs, the drug regulatory department has required related companies and units to take risk control measures such as suspending sales and use, recalling , and conducting investigations into the reasons for non-compliance and making practical rectifications.
In addition, the State Food and Drug Administration requires relevant provincial drug regulatory authorities to organize investigations into suspected illegal activities of the above-mentioned enterprises and units in accordance with the " Drug Administration Law of the People's Republic of China " and make the investigation results public in accordance with regulations.
Source: The editor of People's Daily
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