What is a “Drug Recall”? In what circumstances might one occur?

A medicine recall is an action to retrieve one or more batches of medicines already distributed on the market. It is an important measure to protect the public from medicines that may pose a risk. A recall may be initiated voluntarily by a manufacturer or distributor, or carried out compulsorily at the request of the Department of Health. Recalls may be triggered by various reasons, most commonly quality issues (such as incorrect ingredient content, impurities or packaging errors), safety issues (such as unexpected serious adverse reactions) or compliance issues (such as incorrect label information or use of unapproved raw materials). Recalls are classified by risk level, from the most urgent Class I recall, requiring retrieval to the patient level, to Class III, requiring retrieval only at the wholesale and retail levels. Licensed wholesalers and manufacturers must establish an effective recall procedure to ensure that, when needed, the distribution of affected medicines can be traced quickly and accurately and downstream customers notified.