Final answer:
A Class I medication recall is when the FDA determines a drug is dangerous and must be removed from the market. An example was the proposed reclassification of Hydrocodone in 2013 due to its safety and addictiveness.
Step-by-step explanation:
The subject of the Class I medication recall refers to a situation where the U.S. Food and Drug Administration (FDA) has determined that a drug presents significant and immediate danger to patients and it must be removed from the market. A Class I recall may be issued if a medication is found to have serious side effects, is tainted with harmful substances, or is otherwise unsafe.
An example of this is the proposed reclassification of Hydrocodone in 2013, directed by Janet Woodcock, M.D., the Director of the Center for Drug Evaluation and Research. The reason for this proposed reclassification was related to the safety and addictiveness of the drug. This represents a case where a medication had serious implications for patient health and was subsequently recalled.
Learn more about Class I medication recall