Class I Recall - a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Class II Recall - a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.
Class III Recall - a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
- See more at: http://www.raps.org/Regulatory-Focus/News/2014/08/11/20005/Number-of-Drug-Recalls-Surges-at-FDA-Led-by-Mid-Level-Concerns/#sthash.ixY5z8kU.dpuf
