Table 1 Classification of quality deviations according to ANVISA regulation
From: Recall of substandard medicines in Brazil during the period 2010–2018
Classification | Definition |
|---|---|
Class I | Situation in which there is a high probability that the use or exposure to a drug could cause a health risk resulting in death, threat to life or permanent harm |
Class II | Situation in which there is a high probability that the use of or exposure to a drug may cause temporary harm to health or that may be reversible by drug treatment |
Class III | Situation in which there is a low probability that the use or exposure to a drug could cause adverse health consequences |