Generic drugmaker Aurobindo Pharma USA is recalling its antidepressant drug Mirtazapine because of a labeling error.
The affected lot was labeled as Mirtazapine 7.5 milligram, but it may contain 15 milligram tablets. The expiration date on lot 03119002A3 is March 2022.
Taking a higher dose of the drug than expected may increase risk of sedation, nausea, increased reflexes, agitation, tremors and more, the company warned.
The drugmaker is notifying distributors and is arranging for the return of the tablets.
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