Five drugs were investigated, and the Food and Drug Administration requested the suspension of sales and recall, involving amoxicillin granules, Huanglian Shangqing tablets.
On April 26, the Guangdong Provincial Food and Drug Administration successively issued a notice on the information of the second phase of the random inspection of drugs.
According to the notice, according to the 2020 Guangdong Drug Sampling Inspection Plan, the Guangdong Drug Administration has organized random drug quality inspections on drug production and distribution enterprises and medical institutions across the province.
According to the first notice of 2021, the province has recently spot-checked 1,863 batches of drugs from 797 varieties of 38 drug manufacturers, 492 drug distributors, and 160 medical institutions.
After verification and confirmation, the current sampling information is announced as follows: 1855 batches of 792 varieties have been tested to meet the drug standard requirements, and 5 batches of 5 varieties have been tested and do not meet the drug standard requirements.
According to the second notice in 2021, the province has recently spot-checked and tested 31 batches of drugs from 3 drug manufacturers, 10 drug distributors, and 25 varieties.
After verification, it is confirmed that they are in compliance with the drug standards.
It is worth noting that in the first notice, 5 drugs were unqualified in random inspections, all of which were commonly used preparations, namely Amoxicillin Granules, Huanglian Shangqing Tablets, Trollius Capsules, Norfloxacin Capsules, Difen Hydrochloride Nido tablets.
The main non-compliance items include microbial limit, dissolution, ointment content and content determination.
For the above unqualified drugs, the Guangdong Provincial Food and Drug Administration requires relevant enterprises and units to take risk control measures such as suspension of sales and use, recalls and other risk control measures for unqualified drugs, and at the same time organize the production and sale of counterfeit and substandard drugs to manufacturers and sampled units in accordance with relevant laws and regulations The violations of the law are investigated and dealt with, and the investigations can be found on the websites of our bureau and the market supervision bureaus of cities and counties.
At the same time, the Guangdong Provincial Food and Drug Administration reminds consumers that consumers should purchase medicines in legal and formal medical institutions, pharmacies, etc.
and obtain relevant storage certificates; when purchasing medicines, they should pay attention to the relevant signs of the outer packaging, such as production date, expiration date, manufacturer, and approval.
Whether the document number is complete and whether it is within the validity period.
If necessary, you can log on to the basic database of the National Medical Products Administration (NMPA) website ( to check and verify the relevant information of drug registration; after purchasing the drug, follow the instructions Storage conditions Store the medicines, and take the medicines according to the doctor's instructions or usage and dosage.
Pay special attention to the adverse reactions, contraindications, and precautions on the instructions.
Attachment: Analysis of related items of non-compliant drugs
Dissolution: refers to the rate and extent of the dissolution of active drugs from tablets, capsules or granules under specified conditions.
Microbial limit: check the degree of contamination of non-specified sterilized preparations and their raw materials and auxiliary materials by microorganisms.
The inspection items include the number of bacteria, molds, and yeasts.
Content determination: refers to the use of chemical, instrumental or biological methods to determine the content of active ingredients in raw materials and preparations.