8 August 29, The official website of the State Food and Drug Administration issued the "Notice of the State Food and Drug Administration on 20 batches of drugs that do not meet the regulations (No. 39, 2022)". The full text of the notice is as follows:
State Food and Drug Administration About 20 Notification of batches of drugs that do not meet regulations
(No. 39 of 2022)
has been inspected by China Institute of Food and Drug Control and other 6 drug inspection agencies, and is marked as Zhengzhou Ruilong Pharmaceutical Co., Ltd. and other 20 batches of Lithospermum and other medicines produced by 9 companies. Does not comply with regulations. The relevant information is now announced as follows:
1. After inspection by the Fujian Provincial Institute of Food and Drug Quality Inspection, 2 batches of theophylline injection labeled produced by Shanxi Taiyuan Pharmaceutical Co., Ltd. (formerly Taiyuan Pharmaceutical Factory) are not Comply with regulations, items that do not comply with regulations are visible foreign objects.
After inspection by the Jilin Provincial Institute for Drug Control, it was marked as a batch of Agarwood Huazhi Pills produced by Hebei Bianque Pharmaceutical Co., Ltd. that did not meet the regulations. The non-compliant item was the difference in filling volume.
was inspected by Jiangxi Institute of Drug Inspection and Testing , and the three batches of Huoxiang Zhengqi Water produced by Sichuan Tianfu Kangda Pharmaceutical Group Fuqing Pharmaceutical Co., Ltd. and Taiji Group Sichuan Nanchong Pharmaceutical Co., Ltd. did not meet the requirements. According to the regulations, the items that do not meet the regulations are the amount of methanol .
was inspected by the Guangdong Provincial Institute for Drug Control and marked as . A batch of Longze Bear Bile Capsules produced by Changchun Puhua Pharmaceutical Co., Ltd. did not meet the regulations. The items that did not meet the regulations were microbial limits.
was inspected by the China Institute of Food and Drug Control and was labeled as three batches of chrysanthemums produced by Yancheng Traditional Chinese Medicine Pieces Co., Ltd. that did not meet the regulations. The non-compliant items were banned pesticide residues.
was inspected by the Gansu Provincial Institute for Drug Control and marked as 1 batch of Rubia produced by Yunnan Jianantang Biotechnology Co., Ltd. did not meet the regulations. The non-compliant items include traits and identification; it was marked as Guilin Zhongnan (Bozhou) Pharmaceutical Technology The two batches of madder produced by the company did not meet the regulations. The items that did not meet the regulations included properties, identification, total ash content , acid-insoluble ash content, and leachables.
After inspection by the China Institute of Food and Drug Control, a batch of lithospermum produced by Guilin Zhongnan (Bozhou) Pharmaceutical Technology Co., Ltd. did not meet the regulations. The non-compliant item was content measurement; it was labeled as Zhengzhou Ruilong Pharmaceutical Co., Ltd. The 6 batches of Lithospermum produced did not meet the regulations, and the items that did not meet the regulations were traits.
2. For the above-mentioned drugs that do not meet the regulations, the drug regulatory department has required relevant enterprises and units to take risk control measures such as suspending sales and use, recalling, etc., conduct investigations into the reasons for non-compliance, and make practical rectifications.
3. The State Food and Drug Administration requires the relevant provincial drug regulatory authorities to organize investigations into suspected illegal activities of the above-mentioned enterprises and units in accordance with the "Drug Administration Law of the People's Republic of China" and make the investigation and punishment results public in accordance with regulations.
is hereby notified.
Attachment: List of 1.20 batches of non-compliant drugs
2. Little knowledge about non-compliant items
State Food and Drug Administration
August 25, 2022
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Editor: Hu Zhaoyang
Preliminary review: Jia Enfang, Gu Shichuang
Final review: Li Heng
