South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

What is a Class 1 recall?

1. A recall of products due to minor packaging issues

2. A recall due to serious adverse effects including death

3. A voluntary recall due to manufacturer concerns

4. A recall of non-drug products

The correct answer is: A recall due to serious adverse effects including death

A Class 1 recall is designated for situations in which there is a reasonable probability that using or being exposed to a product will cause serious adverse health consequences or death. This classification is the most serious type of recall and is typically associated with defects that pose a significant risk to consumers, such as contaminated medications or medical devices that could lead to severe health complications. In the context of the other options, a recall due to minor packaging issues does not imply any immediate danger to consumer health and would not fall under Class 1. Similarly, a voluntary recall initiated by a manufacturer due to concerns that do not present a high risk would typically not be classified as a Class 1 recall unless it is demonstrated that the issue could cause serious harm. Lastly, a recall of non-drug products does not apply in this context, as Class 1 recalls specifically pertain to medical products regulated by health authorities. Thus, option B accurately captures the essence and seriousness of a Class 1 recall.