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Notice from the State Drug Administration on 22 batches of drugs not meeting regulations

(No. 48 of 2023)

After inspection by five drug inspection agencies including the Hainan Provincial Drug Inspection Institute, 22 batches of drugs including Xuefu Zhuyu Tablets produced by 14 companies including Shaanxi Haitian Pharmaceutical Co., Ltd. did not comply with regulations. The relevant situation is now announced as follows:

1. After inspection by the Hainan Provincial Drug Inspection Institute, 7 batches of Xuefu Zhuyu tablets marked as produced by Shaanxi Haitian Pharmaceutical Co., Ltd. were found to be non-compliant with the regulations. The non-compliant items were identified.

After inspection by Zhejiang Provincial Food and Drug Inspection Institute, 9 batches of fried Chinese jujube seeds labeled as produced by Hebei Hu's Yubo Pharmaceutical Co., Ltd., Harbin Runhe Chinese Medicine Pieces Processing Factory, Anhui Jianyitang Chinese Medicine Pieces Co., Ltd., Anhui Jucantang Chinese Medicine Pieces Co., Ltd., Anhui Baicui Jinfang Pharmaceutical Co., Ltd., Bozhou Jingfu Chinese Medicine Pieces Co., Ltd., Henan Juren Chinese Medicine Pieces Co., Ltd., Hunan Rongkang Chinese Medicine Pieces Co., Ltd., and Chongqing Zhongmiao Pharmaceutical Co., Ltd. were found to be non-compliant with regulations. The non-compliant items included moisture, properties, identification, and content determination.

After inspection by Chongqing Food and Drug Inspection and Testing Institute, a batch of Danshen formula granules marked as produced by Henan Hongri Kangrentang Pharmaceutical Co., Ltd. was found to be non-compliant with regulations, including fingerprint spectrum and content determination.

After inspection by the Ningxia Hui Autonomous Region Drug Inspection Institute, a batch of Radix Rehmanniae marked as produced by Heilongjiang Wanda Chinese Medicine Pieces Technology Co., Ltd. was found to be non-compliant with regulations, and the item that did not meet the regulations was the total ash content.

After inspection by the China Food and Drug Inspection Institute, four batches of Ligustrum lucidum labeled as produced by Hebei Guorentang Pharmaceutical Co., Ltd., Harbin Runhe Chinese Medicine Pieces Processing Factory, Heilongjiang Wanda Chinese Medicine Pieces Technology Co., Ltd., and Xinjiang Enze Chinese Medicine Pieces Co., Ltd. were found to be non-compliant with regulations, with the largest item being water content.

2. For the above-mentioned drugs that do not meet the requirements, the drug supervision and administration department has required relevant companies and units to adopt risk control measures such as suspension of sales and use, and recall, to investigate the reasons for non-compliance and to carry out rectification in earnest.

3. The State Food and Drug Administration requires relevant provincial-level drug supervision and administration departments to organize investigations into the 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 to make the results of the investigation and punishment public in accordance with regulations.

This is to announce.

Appendix: 1. List of 22 batches of drugs that do not meet the requirements

2. Tips for projects that do not meet the requirements

State Drug Administration

September 25, 2023

Planning and production

Source: National Drug Administration website

Editor: Yinuo