Announcement of the State Drug Administration on 15 batches of drugs that do not meet the requirements (No. 49 of 2021)

After inspection by 7 drug inspection institutions including Gansu Institute for Drug Control and other inspections, 15 batches of drugs, including Bupleurum (North Bupleurum) produced by 14 companies including Anhui Jishantang Traditional Chinese Medicine Technology Co.
, Ltd.
, were not in compliance with the regulations
.
The relevant information is hereby notified as follows: 1.
A batch of penciclovir cream produced by Hubei Keyi Pharmaceutical Co.
, Ltd.
has been inspected by the Heilongjiang Provincial Drug Inspection and Research Center and is labeled as non-compliant, and the non-compliant items are traits
.
According to the inspection by Fujian Food and Drug Quality Inspection Institute, a batch of chloramphenicol eye drops produced by Guangdong Hongying Technology Co.
, Ltd.
is not in compliance with the regulations, and the non-compliant items are related substances
.
According to the inspection by Shandong Food and Drug Inspection and Research Institute, a batch of brain spirit capsules produced by Jiangxi Yaodu Zhangshu Pharmaceutical Co.
, Ltd.
is not in compliance with the regulations, and the non-compliant item is moisture
.
According to the inspection by Beijing Institute for Drug Control, a batch of Xinnaoxin tablets produced by Hubei Ji'antang Pharmaceutical Co.
, Ltd.
did not meet the requirements, and the items that did not meet the requirements were weight differences
.
After inspection by Chongqing Food and Drug Inspection and Testing Research Institute, a batch of Zhuanggu Musk analgesic ointment produced by Jiuzhaigou Natural Pharmaceutical Group Co.
, Ltd.
is not in compliance with the regulations, and the non-compliant items are the cream content
.
According to the inspection by Hubei Institute of Drug Administration and Inspection, a batch of Atractylodes japonicus produced by Beijing Boaitang Anguo Chinese Medicine Technology Co.
, Ltd.
is not in compliance with the regulations, and the items that do not meet the regulations are content determination
.
The 2 batches of Bupleurum produced by Guangxi Lanzheng Pharmaceutical Co.
, Ltd.
and Minxian Guiqitang Pharmaceutical Co.
, Ltd.
were inspected by the Gansu Institute for Drug Control and were not in compliance with the regulations, and the non-compliant items were impurity; labeled as Hebei The 5 batches of Bupleurum (North Bupleurum) produced by Yuekang Zhide Pharmaceutical Co.
, Ltd.
, Anhui Jishantang Chinese Medicine Technology Co.
, Ltd.
, Bozhou Zhangzhongjing Chinese Medicine Pieces Co.
, Ltd.
, and Guangdong Tiancheng Chinese Medicine Pieces Co.
, Ltd.
do not meet the requirements.
Compliance items are impurities; 1 batch of Bupleurum (Vinegar Bupleurum) produced by Hunan Xinhengtang Traditional Chinese Medicine Technology Co.
, Ltd.
does not meet the regulations, and non-compliant items are traits; labeled as Suzhou Tianling Chinese Medicine Decoction Pieces Co.
, Ltd.
1 batch of Bupleurum (root) does not meet the regulations, and the items that do not meet the regulations are impurities
.
2.
For the above-mentioned non-compliant drugs, the drug supervision and administration department has required relevant enterprises and units to take risk control measures such as suspension of sales and use, recalls, etc.
, to investigate the reasons for non-compliance and effectively rectify them
.
3.
The State Drug Administration requires the relevant provincial drug regulatory authorities to organize investigations into the illegal activities of the above-mentioned enterprises and units producing and selling counterfeit and inferior drugs in accordance with the "Pharmaceutical Administration Law of the People's Republic of China", and to disclose the results of investigations in accordance with regulations
.
Hereby inform
.
Attachment: List of 1.
15 batches of non-compliant drugs 2.
Little knowledge of non-compliant items State Drug Administration July 14, 2021 State Drug Administration Announcement No.
49 of 2021 Annex 1.
docx State Drug Administration 2021 Annex 2 of Circular No.
49 of 2015.
doc