The company announced the recall in the US through the US Food and Drug Administration (FDA) on New Year’s Eve, with the lot number of the affected batch being 03119002A3.
The product had reached the consumer level, with the manufacturer, Aurobindo, stating that the risks of a higher than expected dose could be increased risk of sedation, agitation, tremors, and sweating. The symptoms could potentially contribute to falls in the elderly or motor vehicle accidents in adults.
Mirtazapine tablets of various strength are used as a treatment for major depressive disorder.
The company has notified distributors and is arranging for the return of the recalled product.
Towards the end of last year, Aurobindo also announced the recall of statin medication, after the company again suffered from an issue with some bottles being incorrectly labelled.