Difficulty: Easy

Average Score: 100%

Which of the following might cause a Class III recall?

Rationale

A package label says 100 tablets, but the package contains only 50 tablets.

A Class III recall occurs when a product is deemed to be not likely to cause any adverse health consequences, but may still violate labeling regulations or quality standards. In this case, a package label discrepancy that misleads consumers represents a minor violation, thus fitting the criteria for a Class III recall.

A (A package label says 100 tablets, but the package contains only 50 tablets.) CORRECT

This situation involves a labeling error that misrepresents the quantity of product, which can lead to consumer confusion or dissatisfaction. While it doesn’t pose a direct health risk, it violates packaging regulations, making it appropriate for a Class III recall.

B (A patient death has resulted from the use of the product.) YOUR ANSWER

This scenario indicates a serious risk and is likely to result in a Class I recall, which is the most severe level of recall. Class I recalls are reserved for products that pose a significant risk of injury or death, making this option inappropriate for a Class III classification.

C (A high-dose time-release opioid analgesic patch is leaking medication.) YOUR ANSWER

A leaking medication patch poses a significant safety hazard, particularly with opioids that can lead to overdose. This would also warrant a Class I recall due to the immediate risk of harm to patients, thus disqualifying it from being classified as a Class III recall.

D (A package label says 50 mg tablets, but the package contains 500 mg tablets.) YOUR ANSWER

This discrepancy represents a serious risk of potential overdose and misdosing, as it could lead to administering an incorrect dose. Such a situation would typically result in a Class I recall, due to the direct health threats involved, rather than a Class III recall.

Conclusion

A Class III recall is appropriate for issues that may not pose a significant health risk but still involve regulatory violations. In this case, the incorrect labeling of tablet quantity represents a minor concern that can mislead consumers without posing an immediate health threat. The other options present serious health risks, qualifying them for higher-level recalls.

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