Rhode Island Multistate Pharmacy Jurisprudence (MPJE) Practice Exam

What does a Class I recall indicate about a product?

1. It is the least serious type of recall

2. It could cause serious health problems or death

3. It primarily involves labeling issues

4. It is a routine inspection recall

The correct answer is: It could cause serious health problems or death

A Class I recall signifies that a product poses a significant risk to health, with the potential to cause serious health problems or even death. This type of recall is the most severe classification established by the FDA and indicates a critical safety concern. When a Class I recall is issued, it suggests that the product in question should be immediately removed from the market or reassessed for safety to protect consumers. The other classifications do not carry the same level of seriousness. A Class II recall, for example, may involve products that could cause temporary or medically reversible adverse effects but are unlikely to cause serious harm. Labeling issues, which may fall under Class III recalls, typically do not pose significant health risks but could still mislead consumers. Routine inspections are not associated with the recall classifications and are separate processes designed to ensure ongoing compliance with safety regulations.