When is a Class II drug recall issued?

A Class II drug recall is issued when there is a probability of temporary adverse health events that could occur from the use of the drug. This level of recall indicates a situation where exposure to the product may cause a reversible or manageable adverse effect. It often involves products that may not be life-threatening but could lead to significant health issues if consumed.

This classification ensures that patients and healthcare providers are alerted to potential risks, allowing them to take necessary actions, such as discontinuing use of the product or providing alternatives.

In contrast, the other options focus on more extreme or different circumstances. For example, a misbranded drug may lead to a Class I recall if it poses a serious risk to health, and drugs that pose severe health risks or are ineffective fall under different classifications based on the nature of the risk. Therefore, option B accurately represents the circumstances under which a Class II drug recall is appropriate.