What type of recall is indicated when there are serious consequences or death due to a labeling issue?

A Class I recall is implemented when there is a reasonable probability that the use of, or exposure to, a product will cause serious adverse health consequences or death. In this scenario, since the recall is related to serious consequences or even fatality arising from a labeling issue, it is classified as a Class I recall. This type of recall emphasizes the urgent need to address the issue due to the potential risks posed to consumers' health and safety. Immediate action is required to prevent any harm, making it critical for pharmacies and healthcare providers to effectively communicate and respond to such recalls.

In contrast, a Class II recall involves a product that may cause temporary or medically reversible adverse health effects, while a Class III recall concerns products that are not likely to cause any adverse health consequences but violate labeling or manufacturing regulations. There is no classification for a Class IV recall in this context, making Class I the only appropriate designation for the situation described.