Aurobindo Pharma announced the voluntary recall of 1 lot of Mirtazapine Tablets to the consumer level due to a labeling error: bottles labeled as Mirtazapine 7.5mg may contain 15mg tablets. The recall applies to Mirtazapine Tablets with lot number 03119002A3; Exp Date 3/2022.
Mirtazapine is indicated for the treatment of major depressive disorder. Patients exposed to a higher dose than expected may be at increased risk of sedation, agitation, increased reflexes, tremor, sweating, dilated pupils, gastrointestinal distress, nausea, constipation and more.
Consumers are instructed to contact their healthcare professional if they experience any issues related to the recalled product. Adverse reactions may be reported to the FDA’s MedWatch program.
For more information regarding this recall or to report an adverse event, contact Aurobindo Pharma USA by calling (866) 850-2876 and select Option 2; or email [email protected].