Question

question 52

a pharmacy technician is reviewing inventory and identifies a medication that has been recalled by the fda. the technician should recognize that a class i recall indicates which of the following levels of risk?

• the product has a reasonable probability of causing serious adverse health consequences or death.
• the product may cause minor adverse health effects but is unlikely to cause serious harm.
• the product is unlikely to cause any adverse health effects.
• the product has a voluntary market withdrawal and does not represent a significant safety risk.

Explanation:

Define FDA drug recall classifications

Using the Drug Recall Procedures knowledge point

• Class I Recall: A situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
• Class II Recall: A situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
• Class III Recall: A situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Match Class I recall definition to options

• Option 1: "The product has a reasonable probability of causing serious adverse health consequences or death." This matches the definition of a Class I recall.
• Option 2: "The product may cause minor adverse health effects but is unlikely to cause serious harm." This describes a Class II recall.
• Option 3: "The product is unlikely to cause any adverse health effects." This describes a Class III recall.
• Option 4: "The product has a voluntary market withdrawal and does not represent a significant safety risk." This describes a market withdrawal rather than an FDA-classified recall.

Answer:

• (A) The product has a reasonable probability of causing serious adverse health consequences or death. (Correct answer)
• (B) The product may cause minor adverse health effects but is unlikely to cause serious harm.
• (C) The product is unlikely to cause any adverse health effects.
• (D) The product has a voluntary market withdrawal and does not represent a significant safety risk.