Aurobindo Pharma USA Inc. recalled one lot of its mirtazapine tablets due to a label error on the medicine's declared strength.
The voluntary recall was made as 7.5-milligram mirtazapine bottles may contain 15-milligram tablets, the U.S. Food and Drug Administration said in a news release.
Mirtazapine is used for treating major depressive disorder. Taking a higher dose of the drug than expected may increase the risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and other effects.
Aurobindo Pharma USA is also notifying its distributors and is arranging for the return of all of the recalled product.
Aurobindo Pharma USA is the U.S. unit of Indian pharmaceutical company Aurobindo Pharma Ltd.