Communication Dynamics: A Resource in Assuring Drug Quality
Table 1. FDA Recall Classifications
- Class I:
- 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:
- A situation in which the 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:
- A situation in which the use of, or exposure to, a violative product is not likely to cause
adverse health consequences.
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