FDA (Drugs) recall action 84336
The FDA (Drugs) publishes a recall like this one as 2 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 2 pages.
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
The agency’s own wording, quoted from the enforcement report.
AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets that were incorrectly labeled as 7.5 mg. The error affects 500-count bottles distributed nationwide.
AuroMedics Pharma LLC is recalling Mirtazapine 15 mg tablets because some 500-count bottles are incorrectly labeled as 7.5 mg tablets.