Recall of Mirtazapine and FDA Warning Regarding Gabapentinoids Headline Agency Announcements Today

The Agency issued two warnings today, one about a recall due to a drug-strength labeling error for Mirtazapine and the other regarding a potential serious adverse event, breathing difficulties, associated with the use of gabapentinoids.

It appears that there was a label mix-up with a single lot of Mirtazapine and “Aurobindo Pharma USA,