Issued by official website, State Administration of Pharmaceutical Products.
Notice on 16 batch of unqualified drugs
Involving a variety of commonly used drugs.
Check it quickly
Have you been cheated in your little medicine cabinet?
1, suspension of sale and use, recall!
/kloc-List of 0/6 batches of unqualified drugs
For the above-mentioned drugs that do not meet the requirements
Drug supervision and administration department
Relevant enterprises and units have been requested.
Take measures such as suspending sales and use and recalling.
Risk control measures
Because of non-compliance reasons.
Investigate and make rectification.
the State Drug Administration (SDA)
Require the relevant provincial drug supervision and administration departments
According to the Drug Administration Law of People's Republic of China (PRC)
Organize the above-mentioned enterprises and units
Illegal acts of producing and selling fake and inferior drugs
Put on record for investigation
And publicly investigate and deal with the results according to regulations.
2. Unqualified drugs
After inspection by Anhui Food and Drug Inspection Institute, 1 batch of compound clotrimazole cream marked as Hebei Jiuzheng Pharmaceutical Co., Ltd. did not meet the requirements, and the unqualified items were microbial limits; 1 batch of compound clotrimazole cream marked as Shandong Boshan Pharmaceutical Co., Ltd. does not meet the requirements, and the items that do not meet the requirements are the quantity.
The inspection by Shanxi Food and Drug Inspection Institute showed that 1 batch of Gucining capsules produced by Shanxi Tianzhi Pharmaceutical Co., Ltd. and Chongqing Tianzhi Pharmaceutical Co., Ltd. did not meet the requirements, and the unqualified item was moisture.
Three batches of joint analgesic ointment marked as Jiangsu Baiyi Pharmaceutical Co., Ltd. and Jiangxi Ji 'an Lisan Pharmaceutical Co., Ltd. did not meet the requirements, and the items that did not meet the requirements were content determination.
After inspection by Hunan Institute for Drug Control (Hunan Pharmaceutical Accessories Inspection and Testing Center), the 1 batch of Huanglian Shangqing Pills produced by Sichuan Yun Qi Pharmaceutical Co., Ltd. did not meet the requirements, and the nonconformity was a quantity difference.
After inspection by Xizang Autonomous Region Food and Drug Inspection Institute, Keteling Capsule with batch number 1 marked as Yili Pharmaceutical Co., Ltd. did not meet the requirements, and the items that did not meet the requirements were microbial limits.
1 batch of Jiawei Huoxiang Zhengqi Pills produced by Guangzhou Yuehua Pharmaceutical Co., Ltd. was tested by Wuhan Institute of Medicine and Medical Devices, and the unqualified items were identified.
After inspection by China Food and Drug Inspection Institute, three batches of semen Celosiae produced by Anhui Chengjian Chinese Herbal Pieces Co., Ltd., Anhui Xintai Pharmaceutical Co., Ltd. and Chengdu Ji 'ankang Pharmaceutical Co., Ltd. did not meet the requirements, and the items that did not meet the requirements were properties.
After inspection by Gansu Provincial Institute for Drug Control, two batches of Bupleurum produced by Chongqing Zhongmiao Pharmaceutical Co., Ltd. did not meet the requirements, and the items that did not meet the requirements were traits; 1 batch of Bupleurum chinense DC. The production of Guangxi Yulin Tailong Chinese Herbal Pieces Co., Ltd. does not meet the requirements, and the non-compliant items are characterized; 1 batch of Bupleurum chinense DC. ) marked as Sichuan Renhe Traditional Chinese Medicine Pieces Co., Ltd. does not meet the requirements, and the unqualified items are impurities.
See this?
Are many small partners confused?
Microbial limits, content determination ... what are these?
3, does not conform to the provisions of the project knowledge.
1. Microbial limit refers to the microbial control requirements of pharmaceutical preparations that do not directly enter the human environment. Because the drug risk of this kind of pharmaceutical preparation is slightly lower, a certain number of microorganisms can be allowed, but some conditional pathogens can not be detected. Microbial limit is divided into two parts: counting inspection and bacterial control inspection.
Second, the loading capacity is an index reflecting the weight or capacity of drugs, which is suitable for solid, semi-solid and liquid preparations. It is stipulated that the minimum loading test method should be used for inspection. Failure to meet the requirements will lead to insufficient clinical dose.
Three, water refers to the water content in the drug. High moisture content is usually related to factors such as technology, improper packaging and storage and transportation environment.
Four, content determination refers to the determination of the content of effective components in raw materials and preparations by prescribed inspection methods, generally chemical, instrumental or biological determination methods can be used.
5. The loading difference is an index to reflect the uniformity of drugs and one of the important parameters to ensure accurate administration.
6. Identification items are mainly used to distinguish the characteristics of drugs, including microscopic identification and spectral identification. Thin layer chromatography is a commonly used identification method.
VII. The appearance, smell, taste, solubility and physical constants recorded under the characteristics reflect the quality characteristics of drugs to some extent. The characters of Chinese herbal pieces do not meet the requirements, which may involve the deviation of medicinal materials, defects in processing technology and improper storage.
Eight, the impurities mixed in Chinese herbal pieces refers to the substances from the same regulations, but the properties or medicinal parts are inconsistent with the regulations, as well as inorganic impurities from different sources, such as sand, mud, dust, etc.
Drug safety is very important, and there is no room for any mistake!