South Carolina Multistate Pharmacy Jurisprudence Examination (MPJE) Practice Exam

Which type of recall is mandated by regulatory agencies?

1. Medication recall

2. Device recall

3. Cosmetic recall

4. Food recall

The correct answer is: Device recall

Regulatory agencies such as the Food and Drug Administration (FDA) have the authority to mandate recalls for medical devices when there is evidence that a device is defective or poses a risk to health. This type of recall is necessary to protect public safety, ensuring that potentially harmful devices are removed from the market or that corrective actions are taken. In terms of categorization, device recalls can be classified into three classes based on the level of risk involved: 1. Class I recalls, which involve situations where there is a reasonable probability that use of the product will cause serious adverse health consequences or death. 2. Class II recalls, which involve products that may cause temporary or medically reversible adverse effects, or where the probability of serious adverse effects is remote. 3. Class III recalls that are issued for products not likely to cause any adverse health consequences. While medication, cosmetic, and food recalls are also important regulatory actions, they typically do not have the same level of mandated authority specific to device recalls. Medication recalls are often initiated voluntarily by manufacturers, and while agencies can request recalls in certain circumstances, they are not automatically mandated as they are for medical devices. Similarly, recalls for cosmetics and food products follow different protocols and regulations that do not carry the same level of regulatory