- fda recalls

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6 Terms

1
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The drug poses a serious health risk and may cause death or serious harm

Class I

2
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A mislabeled opioid product containing 10x the intended dose

Which FDA drug recall class is this an example of?

Class I

3
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The drug may cause temporary or medically reversible adverse effects - unlikely to cause serious harm

Class II

4
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Continuous glucose monitors with incorrect glucose readings

Which FDA drug recall class is this an example of?

Class II

5
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The drug is not likely to cause any adverse effects

Class III

6
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Labeling error: Omission of safety updates

Which FDA drug recall class is this an example of?

Class III