Potency issues such as degradation before expiration date are associated with which recall class?

• A. Class I
• B. Class III
• C. Class II
• D. Not recalled

Answer: (C)

Potency degradation before expiration means the product may not deliver enough active ingredient to be effective. This creates a potential health issue due to reduced efficacy, but it does not typically pose an immediate life-threatening risk. Class II recalls cover products where the adverse effect is temporary or reversible, or where the probability of serious health consequences is remote, such as subpotent medications failing to achieve the desired therapeutic effect. Therefore, potency issues like degradation before expiration are classified as a Class II recall.