Supplementary Info (Table): Drug Product Recall, Withdrawal, Defect, and Warning Definitions (USA, UK, EU, Canada)
Drug Regulatory Authority / US Food and Drug Administration (FDA) / Medicines and Healthcare Products Regulatory Agency (MHRA) / European Medicines Agency (EMA) / Health Canada
Key Terminology Used / Recall, market withdrawals / Defective medicine and recalls / Defective medicines and recalls / Recall
Key Definitions / “Recalls are actions taken by a firm to remove a product from the market. Recalls may be conducted on a firm's own initiative, by FDA request, or by FDA order under statutory authority.” / “drug which proves to be harmful under normal conditions of use, lacking in therapeutic efficacy and/or the qualitative and quantitative composition of a drug is not as declared. A drug can also be defective if the controls on a drug and/or on the ingredients and the controls at an intermediate stage of the manufacturing process have not been carried out or if some other requirement or obligation relating to the grant of the manufacturing authorisation has not been fulfilled” / A defective medicine is a medicine:
- that may prove to be harmful under normal conditions of use;
- that is found to be lacking in therapeutic efficacy;
- whose benefit-risk balance may not be favourable under the authorised conditions of use, due to:
- faulty manufacture;
- product deterioration;
- detection of falsification;
- non-compliance with the marketing authorisation;
- any other serious quality problem;
- whose qualitative or quantitative composition is not as declared;
- whose controls (on the medicine itself or its ingredients) or whose controls at an intermediate stage of the manufacturing process have not been carried out;
- for which some other requirement or obligation relating to the granting of the manufacturing authorisation has not been fulfilled.
Class I / a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death / requires immediate
recall, because the product poses a serious or life threatening risk
to health / defects that are potentially life-threatening or could cause a serious risk to health / a situation in which there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death
Class II / a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote / specifies a recall within 48 hours, because the defect could harm the patient but is not life threatening. / defects that could cause illness or mistreatment but are not class I / a situation in which the use of, or exposure to, a product may cause temporary adverse health consequences or where the probability of serious adverse health consequences is remote
Class III / a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences / requires action to be taken within 5 days because the defect is unlikely to harm
patients and is being carried out for reasons other than patient safety / defects that may not pose a significant hazard to health but where withdrawal of the medicine may be indicated for some other reason, but which are not class I or II / a situation in which the use of, or exposure to, a product is not likely to cause any adverse health consequences
Class IV / N/A / alerts advise caution
to be exercised when using the product, but indicate that the product poses no threat to patient safety / N/A / N/A
Market withdrawal / occurs when a product has a minor violation that would not be subject to FDA legal action. The firm removes the product from the market or corrects the violation. For example, a product removed from the market due to tampering, without evidence of manufacturing or distribution problems, would be a market withdrawal / N/A / N/A / N/A
Database for Drug Safety Issues / FDA Enforcement Reports / MHRA Defective Medicines Report Centre / Health Canada’s MedEffect Website