72. Which of the following might cause a Class III recall?
Answer: A
A package label says 100 tablets, but the package contains only 95 tablets
A Class III recall may be initiated when a product is not likely to cause adverse health consequences, such as a packaging error where the number of tablets is misrepresented. In this case, the discrepancy in the count of tablets does not pose an immediate risk to health, thus fitting the criteria for a Class III recall.
A) A package label says 100 tablets, but the package contains only 95 tablets
This option represents a minor packaging error that could lead to consumer dissatisfaction or inconvenience but does not present a serious health risk. Class III recalls are typically associated with situations where the product is unlikely to cause any adverse health effects, aligning perfectly with this scenario.
B) A patient death has resulted from the use of the product
This situation would likely lead to a Class I recall, as it involves serious health risks and potential fatal outcomes. Class I recalls are reserved for products that could cause serious health consequences or death, making this option inappropriate for a Class III designation.
C) A high-dose time-release opioid analgesic patch is leaking medication
A leaking opioid patch poses a significant risk of overdose or adverse effects, which would necessitate a Class I recall due to the serious health implications. Thus, this option does not meet the criteria for a Class III recall.
D) A package label says 50 mg tablets, but the package contains 500 mg tablets
This mismatch represents a serious risk of overdose and potential health consequences, warranting a Class I recall. The severity of the situation clearly exceeds the threshold for a Class III recall.
Conclusion
The correct answer, indicating that a package label misstates the number of tablets, is classified as a Class III recall since it does not pose a significant risk to health. In contrast, the other options involve potential health hazards that would necessitate higher-class recalls, reinforcing that Class III recalls are reserved for less severe issues.