National Medical Products Administration: These 15 batches of drugs do not comply with regulations! Inspection | Compliant with regulations | Drug
The website of the National Medical Products Administration issued a notice today regarding 15 batches of drugs that do not comply with regulations.
After inspection by 8 drug inspection institutions including Guangzhou Drug Inspection Institute, it was found that 15 batches of drugs, including Fukang tablets, produced by 15 companies including the Revised Pharmaceutical Group Co., Ltd., did not meet the regulations. The relevant situation is hereby announced as follows:
After inspection by the Fujian Provincial Institute of Food and Drug Quality Inspection and Research, it was found that a batch of pentoxifylline injection produced by Xi'an High tech Shaanxi Jinfang Pharmaceutical Co., Ltd. does not meet the requirements, and the non compliant items are visible foreign objects.
After inspection by the Guizhou Provincial Food and Drug Inspection Institute, it was found that a batch of vitamin B6 injection produced by Sichuan Meidakang Huakang Pharmaceutical Co., Ltd. does not meet the requirements, and the non compliant items are visible foreign objects.
After inspection by the Ningxia Hui Autonomous Region Drug Inspection and Research Institute, it was found that one batch of ursodeoxycholic acid tablets produced by Hubei Ruize Pharmaceutical Co., Ltd. on behalf of Hubei Xinankang Pharmaceutical Co., Ltd. does not meet the requirements. The non compliant item is content determination.
After inspection by the Guangzhou Institute of Drug Control, it was found that the first batch of Fukang tablets produced by the Revised Pharmaceutical Group Co., Ltd. did not meet the requirements, and the non-compliance item was the microbial limit.
After inspection by Chengdu Institute of Drug Control and Research, it was found that two batches of Sanhuang tablets produced by Henan Jishi Pharmaceutical Co., Ltd. and Guangxi Jinye Pharmaceutical Co., Ltd. do not meet the requirements, and the non compliant item is Tu Da Huang glycoside.
![National Medical Products Administration: These 15 batches of drugs do not comply with regulations! Inspection | Compliant with regulations | Drug](https://a5qu.com/upload/images/2bda037891ce904c5fbdbd5fc139aaaa.jpg)
After inspection by Chongqing Food and Drug Inspection and Testing Institute, it was found that a batch of Xingsu cough syrup produced by Sunflower Pharmaceutical Group Hubei Wudang Co., Ltd. commissioned by Sunflower Pharmaceutical Group Longzhong Co., Ltd. does not meet the requirements, and the non compliant item is the pH value.
After inspection by the Zhejiang Provincial Institute of Food and Drug Inspection and Research, it was found that 5 batches of roasted sour jujube kernels produced by Hebei Quantai Pharmaceutical Co., Ltd., Hebei Qixin Traditional Chinese Medicine Granules and Decoction Co., Ltd., Shaoxing Zhenyuan Traditional Chinese Medicine Decoction Co., Ltd., Anhui Hongkun Pharmaceutical Co., Ltd., and Shandong Bencaotang Traditional Chinese Medicine Decoction Co., Ltd. did not meet the requirements, and the non compliant item was water content.
After inspection by the Ningxia Hui Autonomous Region Drug Inspection and Research Institute, it was found that two batches of Rehmannia glutinosa produced by Chengdu Renjihong Pharmaceutical Co., Ltd. and Sichuan Guangran Traditional Chinese Medicine Decoction Co., Ltd. do not meet the requirements, and the non compliant item is the total ash content.
After inspection by Hebei Medical Device Inspection and Research Institute, it was found that the first batch of Poria cocos peel produced by Anguo Ronghua Bencao Traditional Chinese Medicine Co., Ltd. does not meet the requirements, including total ash and acid insoluble ash.
For the above-mentioned drugs that do not comply with regulations, the drug regulatory department has requested relevant enterprises and units to take risk control measures such as suspending sales and use, recalling, etc., investigate the reasons for non-compliance, and effectively carry out rectification.
The National Medical Products Administration requires relevant provincial drug regulatory departments 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 publicly disclose the results of the investigations in accordance with regulations.