TheFDA classifies recalls into three levels, withClass III being the least severe:
* Class I Recall#Most severe# Issued when a drugmay cause serious harm or death.
* Class II Recall#Moderate severity# The drug may causetemporary or medically reversible adverse effects.
* Class III Recall#Least severe# The productis unlikely to cause harm but violates FDA regulations(e.g., labeling errors, minor packaging issues).
* A. Is issued when there is a reasonable probability that the product will cause serious adverse health consequences or death.##Incorrect
* Describes a Class I recall, not Class III.
* B. Is initiated by the FDA if a manufacturer has violated the adulteration provisions of the Food, Drug, and Cosmetic Act (FDCA).##Incorrect
* FDA action due to adulteration typically leads to Class I or Class II recalls, depending on severity.
* C. Occurs when a product may cause temporary or medically reversible adverse health consequences.
##Incorrect
* Describes a Class II recall, not Class III.
* FDA Drug Recall Guidelines- Defines Class I, II, and III recalls.
* PTCB PTCE Exam Content Outline- Covers recall classifications and pharmacy responsibilities.
* FDA Enforcement Report- Lists real-world examples of Class III recalls (e.g.,mislabeling, incorrect expiration dates).
Why Not the Other Options?Key References: