The National Medical Products Administration has suspended the sale of these drugs! Check your medicine cabinet to see if you have any!

The State Food and Drug Administration issued a notice today that after inspection by 10 drug inspection institutions including the Hubei Provincial Drug Supervision and Inspection Institute, 19 batches of drugs including acetylcysteine ​​injection marked as produced by 16 companies including Ruiyang Pharmaceutical Co., Ltd. did not meet the regulations.

Screenshot of the National Medical Products Administration’s official website

According to the announcement, after inspection by the Liaoning Provincial Drug Inspection and Testing Institute, a batch of erythromycin granules marked as produced by Shanghai Diran Dancheng Pharmaceutical Co., Ltd. was found to be non-compliant with regulations, and the item that did not comply with regulations was content determination.

After inspection by the Hubei Provincial Drug Supervision and Inspection Institute, two batches of acetylcysteine ​​injections marked as produced by Ruiyang Pharmaceutical Co., Ltd. did not meet the regulations, and the non-compliant item was hydrogen sulfide. It is reported that hydrogen sulfide is formed when the thiol group in acetylcysteine ​​in solution (the pharmacological effect of acetylcysteine ​​depends on its ability to break the disulfide bonds in the glycoprotein polypeptide chain in sputum) is unstable and falls off when the temperature rises, which is irritating to the respiratory system.

After inspection by the Guangdong Provincial Drug Inspection Institute, two batches of Longze Bear Bile Capsules marked as produced by Tonghua Zhongsheng Pharmaceutical Co., Ltd. were found to be non-compliant with regulations. The items that did not meet the regulations were properties and disintegration time.

It is reported that the properties include appearance, odor, taste, solubility and physical constants, which reflect the quality characteristics of drugs to a certain extent. If the properties of Chinese herbal medicine pieces do not meet the regulations, it may involve deviations in the species of medicinal materials, defects in the processing process, improper storage, etc. The disintegration time limit refers to the disintegration of oral solid preparations under specified conditions. For preparations that require inspections of dissolution, release, melting time limit or dispersion uniformity, the disintegration time limit will no longer be inspected.

After inspection by the Shandong Provincial Food and Drug Inspection Institute, a batch of ginseng Jianpi pills marked as produced by Darentang Pharmaceutical Factory of Tianjin Sino-Singapore Pharmaceutical Group Co., Ltd. was found to be non-compliant with regulations. The non-compliant item was the difference in filling volume.

After inspection by the Tibet Autonomous Region Food and Drug Inspection Institute, a batch of fifteen-flavor black pills labeled as produced by the Tibet Changdu Tibetan Medicine Factory was found to be non-compliant with regulations. The non-compliant items were weight difference and microbial limits.

It is reported that microbial limits are microbial control requirements for pharmaceutical preparations that do not directly enter the human body. Since the use risk of such pharmaceutical preparations is slightly lower, a certain number of microorganisms can be allowed to exist, but some conditional pathogens must not be detected. Microbial limits are divided into two parts: count inspection and control bacteria inspection.

After inspection by the Henan Provincial Food and Drug Inspection Institute, two batches of mugwort leaves labeled as produced by Harbin Songshantang Pharmaceutical Co., Ltd. and Sichuan Jiuweige Chinese Medicine Pieces Co., Ltd. were found to be non-compliant with regulations. The items that did not comply with regulations were all content determination.

After inspection by Sichuan Provincial Drug Inspection Institute (Sichuan Provincial Medical Device Testing Center), a batch of Sichuan Achyranthes bidentata marked as produced by Hubei Mintai Pharmaceutical Co., Ltd. was found to be non-compliant with regulations, and the item that did not meet the regulations was its properties.

After inspection by the China Food and Drug Inspection Institute, three batches of chrysanthemums labeled as produced by Jiangsu Donglian Pharmaceutical Co., Ltd., Anhui Wansheng Chinese Medicine Pieces Co., Ltd., and Hunan Songlingtang Chinese Medicine Pieces Co., Ltd. were found to be non-compliant with regulations. The non-compliant items were all the residues of banned pesticides.

After inspection by the Gansu Provincial Institute of Drug Inspection, four batches of madder marked as produced by Guangzhou Weida Chinese Medicine Pieces Co., Ltd., Sichuan Yuanshangcao Chinese Medicine Pieces Co., Ltd., and Sichuan Yunbotang Pharmaceutical Co., Ltd. were found to be non-compliant with regulations, and the non-compliant items included properties, microscopic identification, and extracts; one batch of madder (madder charcoal) marked as produced by Sichuan Xinkang Chinese Medicine Pieces Co., Ltd. was found to be non-compliant with regulations, and the non-compliant item was properties.

After inspection by the Anhui Provincial Institute of Food and Drug Inspection, a batch of peach kernels marked as produced by Zhangshu Qingren Chinese Medicine Pieces Co., Ltd. did not meet the regulations, and the non-compliant item was the carbonyl value. It is reported that the carbonyl value reflects the amount of carbonyl compounds and other substances produced when the oil-containing Chinese medicinal materials and slices are rancid, which may be related to improper storage.

The National Medical Products Administration stated that for the above-mentioned drugs that do not meet the requirements, the drug supervision and management 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 a practical manner.

In addition, the State Food and Drug Administration requires relevant provincial drug supervision and management departments to organize an investigation 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 investigation and punishment results public in accordance with regulations.

Source: People's Daily Online

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