Announcement of the State Drug Administration on 18 batches of drugs that do not meet the requirements (No. 59 of 2021)

After inspection by 7 drug inspection institutions including Anhui Food and Drug Inspection and Research Institute, 18 batches of drugs, including cough peach powder, produced by 17 companies including Shaanxi Lijun Modern Chinese Medicine Co.
, Ltd.
, were not in compliance with the regulations
.
The relevant information is hereby notified as follows: 1.
A batch of compound bismuth aluminate tablets produced by Inner Mongolia Kaimeng Pharmaceutical Co.
, Ltd.
is not in compliance with the regulations after inspection by the Heilongjiang Provincial Drug Inspection and Research Center.
The non-compliant items are weight differences
.
A batch of terazosin hydrochloride tablets produced by Wuhan Dongxin Pharmaceutical Technology Co.
, Ltd.
was inspected by the China Institute for Food and Drug Control, and it was labeled as dissolution
.
The Yunnan Provincial Food and Drug Supervision and Inspection Institute showed that a batch of Chuanbei Qingfei Syrup produced by Wuhan Xinrui Pharmaceutical Co.
, Ltd.
was not in compliance with the regulations, and the non-compliant items were the microbial limit
.
After inspection by Anhui Food and Drug Inspection and Research Institute, the 2 batches of Cough Peach Blossom Powder produced by Shaanxi Lijun Modern Chinese Medicine Co.
, Ltd.
were not in compliance with the regulations, and items that did not meet the regulations were identified
.
After inspection by Hubei Provincial Institute of Drug Supervision and Inspection, a batch of Atractylodes japonicus (fried atractylodes with bran) produced by Anhui Wukeng Chinese Medicine Decoction Pieces Co.
, Ltd.
did not meet the requirements.
The non-compliant items included traits, identification, total ash and content determination
.
The two batches of Bupleurum (Bupleurum vinegar) produced by Henan Huaxia Medicinal Materials Co.
, Ltd.
and Hunan Liucheng Traditional Chinese Medicine Decoction Pieces Co.
, Ltd.
were inspected by the Gansu Provincial Institute of Drug Control.
The two batches of Bupleurum spp.
(Bupleurum vinegar) produced by Huaxia Xiangzhong Pharmaceutical Decoction Pieces Co.
, Ltd.
and Yinhua Pharmaceutical Co.
, Ltd.
of Zunyi City did not meet the requirements, and the items that did not meet the requirements were traits
.
After being inspected by Chongqing Food and Drug Inspection and Testing Research Institute, it is labeled as Liaoning Fushuntang Pharmaceutical Co.
, Ltd.
, Anhui Huifeng National Pharmaceutical Co.
, Ltd.
, Hubei Shian Decoction Pieces Pharmaceutical Co.
, Ltd.
, Yangchun Bafang Chinese Medicine Decoction Pieces Co.
, Ltd.
, and Guangxi Dahong Pharmaceutical Co.
, Ltd.
Co.
, Ltd.
, Sichuan Hongpu Pharmaceutical Co.
, Ltd.
, Guizhou Zhongheng Chinese Medicine Co.
, Ltd.
, Shaanxi Duoyao Chinese Medicine Decoction Pieces Co.
, Ltd.
produced 8 batches of mulberry leaves that did not meet the requirements, and the items that did not meet the requirements were traits
.
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: 1.
18 batches of non-compliant drugs list 2.
Small knowledge of non-compliant items National Medical Products Administration August 2, 2021 National Medical Products Administration Circular No.
59 of 2021 Annex 1.
docx National Medical Products Administration 2021 Annex 2 of Circular No.
59 of 2015.
doc