The FDA reports Aurobindo Pharma USA, Inc. is voluntarily recalling Mirtazapine, a medication used for treatment of “major depressive disorder,” due to a label error of the declared strength of a certain lot.
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.
Taking a higher does of the Mirtazapine being recalled 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.
Aurobindo Pharma USA, Inc. is notifying its distributors by letter and is arranging for return of all of the recalled product. Distributors and retailers that have product which is being recalled are urged to return the bottle(s) to place of purchase.
Anyone with medical questions, to report negative reactions to the medication under the recall or for more information can contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 Option 2 or pvg@aurobindousa.com.