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 found to be defective but is unlikely to cause any adverse health consequences. In this case, the discrepancy in the tablet count is a labeling error that does not pose a significant risk to patient safety.
A) A package label says 100 tablets, but the package contains only 95 tablets
This option accurately reflects a potential cause for a Class III recall. The incorrect quantity of tablets does not directly impact patient safety, as it does not involve harmful substances or significant health risks; it primarily affects the consumer's expectations and may lead to non-compliance with treatment.
B) A patient death has resulted from the use of the product
This option clearly represents a serious issue that would lead to a Class I recall, not a Class III recall. A patient death indicates a significant risk to health and safety, which is far more severe than the minor labeling issue described in the correct option.
C) A high-dose time-release opioid analgesic patch is leaking medication
This situation poses a serious risk to patients due to the potential for overdose or misuse of the medication. As such, it would warrant a Class I recall, as it directly affects patient safety and presents a substantial health hazard.
D) A package label says 50 mg tablets, but the package contains 500 mg tablets
This discrepancy represents a significant safety risk, as patients may inadvertently take an overdose of the medication. Consequently, this scenario would also result in a Class I recall due to the immediate danger it poses to consumers.
Conclusion
The only option that aligns with the criteria for a Class III recall is the labeling error regarding the number of tablets. All other options involve serious health risks that would necessitate a higher classification of recall due to their potential to cause significant harm or adverse effects to patients. Thus, option A is the only appropriate choice in this context.