The State Food and Drug Administration notified: 15 batches of drugs did not meet the regulations

The website of the State Food and Drug Administration issued a notice today about 15 batches of drugs that did not meet the regulations.

After inspection by 8 drug inspection institutions including the Guangzhou Drug Inspection Institute, 15 batches of drugs such as Fukang Tablets produced by 15 companies including the Revised Pharmaceutical Group Co., Ltd. did not meet the regulations. The relevant situation is hereby notified as follows:

1. After inspection by the Fujian Food and Drug Quality Inspection Institute, a batch of pentoxifylline injection labeled as produced by Xi'an Gaoke Shaanxi Jinfang Pharmaceutical Co., Ltd. did not meet the requirements, and the items that did not meet the requirements were visible foreign objects.

After inspection by Guizhou Provincial Food and Drug Inspection Institute, a batch of vitamin B6 injection labeled as produced by Sichuan Meidakang Huakang Pharmaceutical Co., Ltd. did not meet the regulations, and the items that did not meet the regulations were visible foreign objects.

According to the inspection by Ningxia Hui Autonomous Region Institute of Drug Control, one batch of ursodeoxycholic acid tablets produced by Hubei Xin'ankang Pharmaceutical Co., Ltd. entrusted by Hubei Ruize Pharmaceutical Co., Ltd. did not meet the requirements, and the non-compliance items were: Content determination.

After being inspected by the Guangzhou Drug Control Institute, a batch of Fukang Tablets marked as being produced by Xiuxiu Pharmaceutical Group Co., Ltd. did not meet the requirements, and the non-compliance items were microbial limits.

According to the inspection by Chengdu Institute of Drug Control, the two batches of Sanhuang Tablets marked as produced by Henan Jishi Pharmaceutical Co., Ltd. and Guangxi Jinye Pharmaceutical Co., Ltd. did not meet the regulations, and the non-compliant item was rhubarb.

According to the inspection by Chongqing Food and Drug Inspection and Testing Institute, one batch of Xingsu cough syrup produced by Sunflower Pharmaceutical Group (Xiangyang) Longzhong Co., Ltd. entrusted by Hubei Wudang Co., Ltd. of Sunflower Pharmaceutical Group did not meet the regulations. The compliance item is pH value.

Tested by Zhejiang Institute of Food and Drug Inspection, it is marked as Hebei Quantai Pharmaceutical Co., Ltd., Hebei Qixin Chinese Medicine Granules Co., Ltd., Shaoxing Zhenyuan Chinese Medicine Co., Ltd., Anhui Hongkun Pharmaceutical Co., Ltd., Shandong Ben The 5 batches of stir-fried jujube kernels produced by Caotang Chinese Herbal Pieces Co., Ltd. did not meet the regulations, and the non-compliant item was water.

After being inspected by the Ningxia Hui Autonomous Region Drug Inspection Institute, the two batches of Digupi produced by Chengdu Renjihong Pharmaceutical Co., Ltd. and Sichuan Guangran Chinese Herbal Pieces Co., Ltd. did not meet the requirements, and the non-compliant items were total ash.

According to the inspection by the Hebei Provincial Institute of Drug and Medical Device Inspection, one batch of Poria cocos skin marked as produced by Anguo Ronghua Herbal Chinese Medicinal Materials Co., Ltd. did not meet the requirements. The non-compliance items included total ash and acid-insoluble ash.

2. For the above non-compliant drugs, the drug regulatory 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 to make rectifications.

3. The State Drug Administration requires the relevant provincial drug regulatory departments to organize investigations into 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 disclose the investigation results in accordance with regulations.