Measures On The Administration Of Drug Recall, issued by the State Food and Drug Administration on December 10, 2007 and took effect on the same day.

1.      What does the term “drug recall” refer to?

The term “drug recall” refers to the condition in which a pharmaceutical enterprise takes measures to recall potentially harmful medicines in a timely manner. The recall procedures do not apply to ascertained fake or inferior medicines.

2.      How many classes is the drug recall divided into and what is the division standard?

Pursuant to the Measures, the drug recall is divided into three classes according to the seriousness of the harm that may be caused: The first class applies to medicines that may cause serious harm to health; the second class applies to medicines that may cause temporary or reversible harm to health; and the third class applies to medicines that generally would not cause harm to health but should be recalled for some other reason.

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