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FDA Medication Recalls

PTCB Flashcards · 15 cards

Card 1 of 157% complete
Question

According to the FDA's recall classification system, which class indicates a reasonable probability that use of the product will cause serious adverse health consequences or death?

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Answer
A.Class I
B.Class II
C.Class III
D.Class IV
Class I recalls represent the most serious category, where there is a reasonable probability of serious health consequences or death. Class II (B) involves a lower probability of serious harm, Class III (C) is unlikely to cause any adverse health consequence, and Class IV (D) is not an FDA recall classification.