Recently
The official website of the State Food and Drug Administration (SFDA) released
Notice on the non-compliance of 16 batches of medicines
These medicines involve a wide range of common medicines
All of these medicines are now in the marketplace.
Hurry up and check
Your family's small medicine cabinet has not been hit
1, Suspension of sales and use, recall!
List of 16 batches of non-compliant medicines
For the above non-compliant medicines
The drug supervision and management department
has
Required the relevant enterprises and units
To take the suspension of the sale and use, recall
Risk control measures
To investigate and effectively rectify the reasons for the non-compliance
To ensure the safety of the drugs, and to ensure that they are not used in a manner that is not inappropriate.
The State Drug Administration (SDA)
requested the relevant provincial drug supervision and administration departments to
organize the investigation of the above enterprises and units
on the basis of the "Chinese People's Republic of China Drug Administration Law"
to produce and sell counterfeit and shoddy medicines in violation of the law
to establish a case.
And according to the provisions of the public investigation results
2, non-compliance with the provisions of the drug situation
Anhui Food and Drug Inspection and Research Institute, labeled as Hebei Jiuzheng Pharmaceutical Company Limited production of a batch of compound clotrimazole cream does not comply with the provisions of the non-compliant items for microbial limit; labeled as Hebei Jiuzheng Pharmaceutical Co. Compliance with the provisions of the project for the microbial limit; labeled as Shandong Boshan Pharmaceutical Co., Ltd. production of a batch of compound clotrimazole cream does not comply with the provisions of the non-compliant items for the loading.
By the Shanxi Provincial Food and Drug Inspection Institute, labeled commissioned by Shanxi Tianzhi Pharmaceutical Co., Ltd. and commissioned by Chongqing Tianzhi Pharmaceutical Co.
By Yunnan Food and Drug Administration Inspection and Research Institute, labeled as Jiangsu Baiyi Pharmaceutical Company Limited, Jiangxi Ji'an Sanli Pharmaceutical Company Limited production of three batches of joint pain cream does not comply with the provisions of the non-compliant items for the determination of content.
Hunan Pharmaceutical Inspection and Research Institute (Hunan Pharmaceutical Excipients Inspection and Testing Center) test, labeled as Sichuan Qiyun Pharmaceutical Company Limited production of a batch of Huanglianqing Pills does not comply with the provisions of the non-compliant items for the loading difference.
By the Tibet Autonomous Region Food and Drug Inspection and Research Institute test, labeled as a force of pharmaceutical companies to produce a batch of cough capsules do not comply with the provisions of the non-compliant items for microbial limit.
By the Wuhan Institute of Drugs and Medical Devices Inspection, labeled as Guangzhou Yuehua Pharmaceutical Co., Ltd. production of a batch of flavor patchouli pills do not comply with the regulations, non-compliance with the requirements of the project for the identification.
Tested by the China Food and Drug Administration Research Institute, labeled as Anhui Jiancheng Traditional Chinese Medicine Drinking Tablets Company Limited, Anhui Xintai Pharmaceutical Company Limited, Chengdu Ji'ankang Pharmaceutical Company Limited production of three batches of Celosia argentea did not comply with the provisions of the non-compliant items for the character.
Gansu Province Drug Inspection and Research Institute test, labeled as Chongqing Zhongmiao Pharmaceutical Company Limited production of two batches of Chaihu does not comply with the provisions of the non-compliant items for the character; labeled as Guangxi Yulin Tailong Traditional Chinese Medicine Drinks Co. Ltd. 1 batch of Chai Hu (Bei Chai Hu) does not comply with the regulations, the non-compliant items for impurities.
Seeing this
Many partners are not confused
Microbial limits, content determination ... What is all this?
3, Non-compliant items of trivia
a. Microbial limit of the microbial control requirements for pharmaceutical preparations that do not directly enter the human body environment. Due to the slightly lower risk of such drug preparations, a certain number of microorganisms can be allowed to exist, but shall not detect some conditionally pathogenic bacteria. The microbial limit is divided into two parts: count check and control bacteria check.
Second, the load is an indicator of the weight or capacity of the drug, applicable to solid, semi-solid, liquid preparations, the provisions should be checked according to the minimum load inspection method, non-compliance will lead to clinical administration of insufficient dosage.
Third, moisture refers to the water content of drugs. High water content is usually related to the process, improper packaging and storage and transportation environment and other factors.
Fourth, content determination refers to the determination of raw materials and preparations in the content of the active ingredient with the prescribed test method, generally can be used chemical, instrumental or biological methods of determination.
Fifth, the loading difference is reflected in the drug uniformity of the indicators, is to ensure accurate administration of one of the important parameters.
VI. Identification items are mainly used to distinguish the characteristics of drugs, the means include microscopic identification, spectral identification, etc., thin layer chromatography is a common identification method.
Seventh, the appearance, odor, taste, solubility and physical constants recorded under the traits, to a certain extent, reflecting the quality characteristics of drugs. The non-compliance of Chinese medicine tablets in the item of traits may involve the deviation of the species of herbs, defective concoctions, improper storage, etc.
VIII.
VIII. The impurities mixed in Chinese medicine tablets refer to the substances that come from the same source but whose traits or medicinal parts are not in accordance with the regulations, as well as the inorganic impurities whose sources are different from the regulations, such as gravel, mud, dust, etc.
It is a good thing that we have a lot of impurities in the Chinese medicine tablets, because they are not the same.
Medicine safety It's crucial to not make the slightest mistake!