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NMPA: 20 batches of drugs are unqualified→ and see foreign bodies visible in injections!

 Last Update: 2022-09-07
 Source: Internet
 Author: User

The original text of the notification

After inspection by 6 drug inspection institutions such as the China Institute of Food and Drug Control, 20 batches of drugs such as comfrey produced by 9 enterprises including Zhengzhou Ruilong Pharmaceutical Co.
, Ltd.
did not meet the regulations
.

1.
The relevant information is hereby notified as follows:

First, the relevant situation is hereby notified as follows: First, the relevant situation is hereby notified as follows: First, the relevant situation is hereby notified as follows:

After inspection by Fujian Food and Drug Quality Inspection and Research Institute, 2 batches of dihydroxypropylphylline injection labeled as produced by Shanxi Taiyuan Pharmaceutical Co.
, Ltd.
(formerly Taiyuan Pharmaceutical Factory) do not meet the regulations, and the items that do not meet the requirements are visible foreign bodies
.
After inspection by Jilin Provincial Institute of Drug Inspection and Research, the 1 batch of agarwood stagnant pills labeled as produced by Hebei Bian que Pharmaceutical Co.
, Ltd.
did not meet the regulations, and the items that did not meet the regulations were the difference in
loading.
After the inspection of Jiangxi Provincial Institute of Drug Inspection and Testing, the three batches of Huoxiang Zhengqi water marked as produced by Sichuan Tianfu Kangda Pharmaceutical Group Fuqing Pharmaceutical Co.
, Ltd.
and Taiji Group Sichuan Nanchong Pharmaceutical Co.
, Ltd.
do not meet the regulations, and the items that do not meet the requirements are methanol
.
After inspection by the Guangdong Provincial Drug Inspection Institute, the 1 batch of Longze bear bile capsules labeled as produced by Changchun Puhua Pharmaceutical Co.
, Ltd.
does not meet the regulations, and the items that do not meet the requirements are microbial limits
.
After inspection by the China Institute of Food and Drug Control, the 3 batches of chrysanthemums labeled as produced by Yancheng Traditional Chinese Medicine Tablets Co.
, Ltd.
did not meet the regulations, and the items that did not meet the requirements were the prohibited pesticide residues
.
After inspection by the Gansu Provincial Institute of Drug Inspection and Research, the 1 batch of madder marked as produced by Yunnan Jian'antang Biotechnology Co.
, Ltd.
does not meet the regulations, and the items that do not meet the requirements include traits and identification;
After inspection by the Gansu Provincial Institute of Drug Inspection and Research, the 2 batches of madder marked as produced by Guilin Zhongnan (Bozhou) Pharmaceutical Technology Co.
, Ltd.
do not meet the regulations, and the items that do not meet the requirements include traits, identification, total ash, acid insoluble ash, and leachables
.
After the inspection of the China Institute of Food and Drug Control, the 1 batch of comfrey marked as produced by Guilin Zhongnan (Bozhou) Pharmaceutical Technology Co.
, Ltd.
does not meet the regulations, and the non-compliant items are content determination;
After inspection by the China Institute of Food and Drug Control, 6 batches of comfrey marked as produced by Zhengzhou Ruilong Pharmaceutical Co.
, Ltd.
do not meet the regulations, and the items that do not meet the requirements are traits
.

After inspection by Fujian Food and Drug Quality Inspection and Research Institute, 2 batches of dihydroxypropylphylline injection labeled as produced by Shanxi Taiyuan Pharmaceutical Co.
, Ltd.
(formerly Taiyuan Pharmaceutical Factory) do not meet the regulations, and the items that do not meet the requirements are visible foreign bodies
.
After inspection by Fujian Food and Drug Quality Inspection and Research Institute, 2 batches of dihydroxypropylphylline injection labeled as produced by Shanxi Taiyuan Pharmaceutical Co.
, Ltd.
(formerly Taiyuan Pharmaceutical Factory) do not meet the regulations, and the items that do not meet the requirements are visible foreign bodies
.
Foreign bodies
are visible.

After inspection by Jilin Provincial Institute of Drug Inspection and Research, the 1 batch of agarwood stagnant pills labeled as produced by Hebei Bian que Pharmaceutical Co.
, Ltd.
did not meet the regulations, and the items that did not meet the regulations were the difference in
loading.
After inspection by Jilin Provincial Institute of Drug Inspection and Research, the 1 batch of agarwood stagnant pills labeled as produced by Hebei Bian que Pharmaceutical Co.
, Ltd.
did not meet the regulations, and the items that did not meet the regulations were the difference in
loading.
Difference in loading volume
.

After the inspection of Jiangxi Provincial Institute of Drug Inspection and Testing, the three batches of Huoxiang Zhengqi water marked as produced by Sichuan Tianfu Kangda Pharmaceutical Group Fuqing Pharmaceutical Co.
, Ltd.
and Taiji Group Sichuan Nanchong Pharmaceutical Co.
, Ltd.
do not meet the regulations, and the items that do not meet the requirements are methanol
.
After inspection by Jiangxi Provincial Institute of Drug Inspection and Testing, the three batches of Huoxiang Zhengqi water marked as produced by Sichuan Tianfu Kangda Pharmaceutical Group Fuqing Pharmaceutical Co.
, Ltd.
and Taiji Group Sichuan Nanchong Pharmaceutical Co.
, Ltd.
do not meet the regulations, and the items that do not meet the requirements are methanol amounts
.

After inspection by the Guangdong Provincial Drug Inspection Institute, the 1 batch of Longze bear bile capsules labeled as produced by Changchun Puhua Pharmaceutical Co.
, Ltd.
does not meet the regulations, and the items that do not meet the requirements are microbial limits
.
After inspection by the Guangdong Provincial Drug Inspection Institute, the 1 batch of Longze bear bile capsules labeled as produced by Changchun Puhua Pharmaceutical Co.
, Ltd.
does not meet the regulations, and the items that do not meet the requirements are microbial limits
.
Microbiological limits
.

After inspection by the China Institute of Food and Drug Control, the 3 batches of chrysanthemums labeled as produced by Yancheng Traditional Chinese Medicine Tablets Co.
, Ltd.
did not meet the regulations, and the items that did not meet the requirements were the prohibited pesticide residues
.
After inspection by the China Institute of Food and Drug Control, the 3 batches of chrysanthemums labeled as produced by Yancheng Traditional Chinese Medicine Tablets Co.
, Ltd.
did not meet the regulations, and the items that did not meet the requirements were the prohibited pesticide residues
.
Pesticide residues are prohibited
.
Pesticide residues are prohibited
.

After inspection by the Gansu Provincial Institute of Drug Inspection and Research, the 1 batch of madder marked as produced by Yunnan Jian'antang Biotechnology Co.
, Ltd.
does not meet the regulations, and the items that do not meet the requirements include traits and identification; After inspection by the Gansu Provincial Institute of Drug Inspection and Research, the 1 batch of madder marked as produced by Yunnan Jian'antang Biotechnology Co.
, Ltd.
does not meet the regulations, and the items that do not meet the requirements include traits and identification; Traits, identification;

After inspection by the Gansu Provincial Institute of Drug Inspection and Research, the 2 batches of madder marked as produced by Guilin Zhongnan (Bozhou) Pharmaceutical Technology Co.
, Ltd.
do not meet the regulations, and the items that do not meet the requirements include traits, identification, total ash, acid insoluble ash, and leachables
.
After inspection by The Gansu Provincial Institute of Drug Inspection and Research, marked as the inspection of the Gansu Provincial Institute of Drug Inspection and Research, guilin Zhongnan (Bozhou) Pharmaceutical Technology Co.
, Ltd.
produced 2 batches of madder does not meet the regulations, and the items that do not meet the requirements include traits, identification, total ash, acid insoluble ash, and leachables
.
Traits, identification, total ash, acid insoluble ash, leachables
.

After the inspection of the China Institute of Food and Drug Control, the 1 batch of comfrey marked as produced by Guilin Zhongnan (Bozhou) Pharmaceutical Technology Co.
, Ltd.
does not meet the regulations, and the non-compliant items are content determination; After the inspection of the China Institute of Food and Drug Control, the 1 batch of comfrey marked as produced by Guilin Zhongnan (Bozhou) Pharmaceutical Technology Co.
, Ltd.
does not meet the regulations, and the non-compliant items are content determination;

After inspection by the China Institute of Food and Drug Control, 6 batches of comfrey marked as produced by Zhengzhou Ruilong Pharmaceutical Co.
, Ltd.
do not meet the regulations, and the items that do not meet the requirements are traits
.
After inspection by the China Institute of Food and Drug Control, marked as after the inspection of the China Institute of Food and Drug Control, 6 batches of comfrey produced by Zhengzhou Ruilong Pharmaceutical Co.
, Ltd.
do not meet the regulations, and the items that do not meet the requirements are traits
.
Properties
.

Second, for the above-mentioned drugs that do not meet the regulations, the drug supervision and management department has required relevant enterprises and units to take risk control measures such as suspension of sales and use, recall, etc.
, to investigate the reasons for the non-compliance and effectively rectify them
.
Second, for the above-mentioned drugs that do not meet the regulations, the drug supervision and management department has required relevant enterprises and units to take risk control measures such as suspension of sales and use, recall, etc.
, to take risk control measures such as suspension of sales and use, recall, etc.
, to investigate the reasons for non-compliance and effectively rectify
them.

The State Drug Administration requires the relevant provincial drug supervision and administration departments to organize a case filing and investigation of the suspected illegal acts of the above-mentioned enterprises and units in accordance with the Drug Administration Law of the People's Republic of China, and to disclose the results of
the investigation and handling in accordance with regulations.

Notice is hereby given
.

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20 batches of non-compliant drug lists

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