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The drug poses a serious health risk and may cause death or serious harm
Class I
A mislabeled opioid product containing 10x the intended dose
Which FDA drug recall class is this an example of?
Class I
The drug may cause temporary or medically reversible adverse effects - unlikely to cause serious harm
Class II
Continuous glucose monitors with incorrect glucose readings
Which FDA drug recall class is this an example of?
Class II
The drug is not likely to cause any adverse effects
Class III
Labeling error: Omission of safety updates
Which FDA drug recall class is this an example of?
Class III