What Are the Most Common Reasons for a Medicine Recall?

Drug recall refers to the drug manufacturer's recall of drugs that have been put on the market and have hidden safety hazards in accordance with prescribed procedures. Potential safety hazards refer to unreasonable dangers that may endanger human health and life safety due to pharmaceuticals due to research and development, production and other reasons. Recall procedures are not applicable to those that have been identified as counterfeit or inferior drugs. ^[1]

Drug recall refers to the drug manufacturer's recall of drugs that have been put on the market and have hidden safety hazards in accordance with prescribed procedures. Potential safety hazards refer to unreasonable dangers that may endanger human health and life safety due to pharmaceuticals due to research and development, production and other reasons. Recall procedures are not applicable to those that have been identified as counterfeit or inferior drugs. ^[1]

Chinese name

Drug recall

Foreign name

drug recall

Law

Administrative Measures for Drug Recall

Drug recall grade classification

Drug recalls fall into two categories and three. Two types are voluntary recall and ordered recall. Among them, the recall order refers to a drug regulatory agency that, after investigation and evaluation, believes that there is a potential safety hazard, and the drug manufacturer should recall the drug without actively recalling it, it should order the drug manufacturer to recall the drug.

The three levels are differentiated according to the severity of the hidden dangers of drug safety. Drug recall can be divided into different levels according to the severity of the potential safety hazards.

(1) First-level recall: the use of the drug may cause serious health hazards;
(2) secondary recall: the use of the drug may cause temporary or reversible health hazards;
(3) Level III recall: the use of the drug will generally not cause health hazards, but it needs to be recalled for other reasons.
A drug manufacturing enterprise shall scientifically design a drug recall plan and organize its implementation based on the recall classification and drug sales and use. Different levels of drug recall require different recall times. The higher the level, the shorter the time required to recall a drug.

Drug recall procedures

First of all, drug manufacturers (foreign pharmaceutical manufacturers that import drugs) should decide to recall the drugs if they have hidden safety hazards.

Second, for the decision to recall drugs, formulate a recall plan and notify relevant drug distributors and users to stop selling and using them within the prescribed time. At the same time, evaluate the effect of the recall, and submit investigation and evaluation reports and recall plans to the provinces, The drug regulatory department of the autonomous region or municipality directly under the Central Government has put on record. Provincial, autonomous region, and municipality-level drug regulatory agencies shall report the investigation and evaluation report and recall plan for the recall of first-level drugs to the State Food and Drug Administration.

Third, the drug regulatory departments of provinces, autonomous regions, and municipalities review the report, evaluate the effect of the recall, and organize experts to review and evaluate if necessary. The review and evaluation conclusions shall be notified to the drug manufacturing enterprise in writing. Where the recall is incomplete or more effective measures need to be taken, the drug supervision and administration department shall require the drug manufacturer to recall or expand the scope of the recall.

Drug recall legal liability

Legally responsible drug regulatory authorities confirm that drug manufacturers have hidden safety hazards in marketed drugs due to violations of laws, regulations, and rules. Administrative penalties shall be imposed in accordance with the law. If the company has taken recall measures to actively eliminate or mitigate the consequences of harm, it shall comply with the Administrative Penalty Law The provisions of "" are lighter or mitigate punishment; violations of the law are minor and timely corrected without causing harmful consequences, no punishment shall be imposed. If a drug manufacturer finds that there is a potential safety hazard in the drug and does not actively recall the drug, the drug regulatory authority shall order the recall of the drug and impose a fine of three times the value of the recalled drug; if it causes serious consequences, the original license-issuing department shall revoke the drug approval certificate Documents until the Drug Production License is revoked. Drug manufacturers that violate other provisions of these Measures shall be warned, ordered to make corrections within a time limit, and fined. Drug regulatory departments and their staff who fail to perform their duties or abuse their powers shall be dealt with in accordance with relevant laws and regulations. ^[2]