Which is a correct classification for the ketorolac injections recalled due to the possibility of particles in the vial?

• A. Class I recall
• B. Class III recall
• C. Class II recall
• D. No recall

Answer: (C)

A recall classification is based on how likely it is that exposure to the product will cause harm and how severe that harm could be. A Class I recall is the most serious: there’s a reasonable chance that use or exposure will cause death or major, irreversible harm. A Class II recall is for exposures that could cause temporary or reversible health problems or where the probability of serious harm is remote, often requiring medical evaluation or intervention. A Class III recall involves a product unlikely to cause adverse health effects.

Finding particles in a sterile injectable vial raises concern, because injecting foreign material could lead to local or systemic issues that may require medical attention, but it isn’t interpreted as presenting a high likelihood of death or irreversible harm. That intermediate risk level fits a Class II recall best. It’s more serious than a minimal-risk Class III but not as severe as a Class I. No recall would be inappropriate because there is a known quality/safety issue that triggers FDA action.