Question

question 68

a class i recall has been presented to the pharmacy. which of the following statements reflects the fda classification of this recall?

there is a chance of temporary adverse effects to the patient.
there is a minor violation not subject to fda legal action.
there is an unlikely chance of adverse effects to the patient.
there is a chance of serious health problems or death to the patient.

Explanation:

Define Class I Recall

Using the Drug Recall Procedures knowledge point

• Class I recalls are the most severe type of FDA recall.
• They involve situations where there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

Evaluate the options

• Option 1 describes a Class II recall (temporary or medically reversible adverse health consequences).
• Option 2 describes a market withdrawal or minor violation (not subject to legal action).
• Option 3 describes a Class III recall (not likely to cause adverse health consequences).
• Option 4 correctly identifies the definition of a Class I recall.

Answer:

• There is a chance of temporary adverse effects to the patient.
• There is a minor violation not subject to FDA legal action.
• There is an unlikely chance of adverse effects to the patient.
• There is a chance of serious health problems or death to the patient. (Correct answer)