Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 of Mirtazapine Tablets to the consumer level.
Officials say the product is being recalled due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.
Taking a higher dose than expected, may increase risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more.
Unexpected levels of sedation in particular can contribute to falls in the elderly or motor vehicle accidents in adults.
Mirtazapine tablets are indicated for the treatment of major depressive disorder and are packaged in 500 count bottles.
The affected lot number for both Mirtazapine Tablets 7.5 mg and Mirtazapine Tablets 15 mg are 03119002A3 Exp 03/2022.
The product can be identified by checking the product name, manufacturer details and batch or lot number on the bottle containing these products.
Aurobindo Pharma USA, Inc. is notifying its distributors by letter and is arranging for return of all of the recalled product.
Distributors/retailers that have product which is being recalled should return the bottle(s) to place of purchase.