A manufacturer recalls a sterile injectable after finding particulate matter that could cause fatal embolism. How does the FDA classify this recall?

Explanation

A Class I recall applies when there is a reasonable probability that use of the product will cause serious adverse health consequences or death, which fits a contaminant capable of causing a fatal event. Class II covers products that may cause temporary or medically reversible harm, and Class III covers products unlikely to cause any adverse health consequence, such as a minor labeling defect. There is no Class IV in the FDA recall classification system.