Announcement of the State Drug Administration on 16 batches of drugs that do not meet the requirements (No. 36 of 2021)

After inspection by 8 drug inspection institutions including Anhui Food and Drug Inspection and Research Institute, 16 batches of drugs including compound clotrimazole cream produced by 14 companies including Hebei Jiuzheng Pharmaceutical Co.
, Ltd.
were not in compliance with the regulations
.
The relevant information is hereby notified as follows: 1.
A batch of compound clotrimazole cream produced by Hebei Jiuzheng Pharmaceutical Co.
, Ltd.
has been inspected by Anhui Food and Drug Inspection and Research Institute.
; 1 batch of compound clotrimazole cream produced by Shandong Boshan Pharmaceutical Co.
, Ltd.
does not meet the requirements, and the items that do not meet the requirements are the filling quantity
.
After inspection by Shanxi Provincial Food and Drug Inspection Institute, it is indicated that the entrusting party is Shanxi Tianzhi Pharmaceutical Co.
, Ltd.
, and the trustee is Chongqing Tianzhi Pharmaceutical Co.
, Ltd.
The first batch of Gucining capsules does not meet the requirements, and the non-compliant items are moisture
.
The three batches of joint pain relief ointment produced by Jiangsu Baiyi Pharmaceutical Co.
, Ltd.
and Jiangxi Ji’an Sanli Pharmaceutical Co.
, Ltd.
were inspected by Yunnan Food and Drug Supervision and Inspection Institute and were not in compliance with the regulations, and the items that did not meet the regulations were content determination
.
A batch of Huanglian Shangqing Pills produced by Sichuan Qiyun Pharmaceutical Co.
, Ltd.
was not in compliance with the regulations after inspection by the Hunan Institute of Drug Inspection (Hunan Pharmaceutical Excipients Inspection and Testing Center)
.
After inspection by the Tibet Autonomous Region Food and Drug Inspection and Research Institute, a batch of Keteling capsules produced by Yili Pharmaceutical Co.
, Ltd.
were not in compliance with the regulations, and the non-compliance items were microbiological limits
.
After inspection by Wuhan Institute of Drug and Medical Device Inspection, a batch of Jiawei Huoxiang Zhengqi Pills produced by Guangzhou Yuehua Pharmaceutical Co.
, Ltd.
is not in compliance with the regulations, and the items that do not meet the regulations are identified
.
After inspection by China National Institute for Food and Drug Control, the three batches of argentea produced by Anhui Jiancheng Chinese Medicine Decoction Pieces Co.
, Ltd.
, Anhui Xintai Pharmaceutical Co.
, Ltd.
, and Chengdu Ji'ankang Pharmaceutical Co.
, Ltd.
did not meet the requirements and did not meet the requirements.
For traits
.
According to the inspection by Gansu Provincial Institute of Drug Inspection, the 2 batches of Bupleurum spp.
produced by Chongqing Zhongmiao Pharmaceutical Co.
, Ltd.
are not in compliance with the regulations, and the non-compliance items are traits; the batch is labeled as the 1 batch produced by Guangxi Yulin Tailong Chinese Medicine Decoction Pieces Co.
, Ltd.
Sub-Bupleurum (North Bupleurum) does not meet the requirements, and the items that do not meet the requirements are traits; the first batch of Bupleurum (North Bupleurum) labeled as Sichuan Renhe Chinese Medicine Decoction Pieces Co.
, Ltd.
does not meet the requirements, and the items that do not meet the requirements 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: 1.
16 batches of non-compliant drugs list 2.
Small knowledge of non-compliant items National Medical Products Administration June 8, 2021 National Medical Products Administration Circular No.
36, 2021 Annex 1.
doc National Medical Products Administration 2021 Annex 2 of Circular No.
36 of 2015.
doc