Aurobindo Voluntarily Recalls One Lot of Mirtazapine Tablets

December 31, 2019 – Aurobindo Pharma has announced a voluntary recall of one lot of Mirtazapine Tablets due to a labeling error. Bottles belonging to lot number 03119002A3 may be labeled as containing 7.5mg tablets when in fact they contain 15mg tablets.

An antidepressant indicated to treat major depressive disorder (MDD), mirtazapine is the generic for Remeron®. Patients who take a higher dose than intended may be at an increased risk of side effects that include sedation, agitation, increased reflexes, tremors, sweating, dilated pupils, gastrointestinal distress, nausea, and constipation. A higher risk of sedation can increase a patient’s risk of falls or motor vehicle accidents.

The recalled lot consists of 500-count bottles with an expiration date of March 2022 and labeled as containing either 7.5mg or 15mg Mirtazapine Tablets. For general questions regarding returns of the recalled product, consumers should contact Qualanex at 1-888-504-2014 or mecall@qualanex.com. Consumers who have medical questions or wish to report an adverse event should contact Aurobindo at 1-866-850-2876 (Option 2) or pvg@aurobindousa.com. If a patient has experienced an adverse event that may be related to use of the recalled product, they should contact their healthcare provider. Adverse events can also be reported to the FDA’s MedWatch program.

Full recall details can be found at the FDA’s website. Benecard Central Fill did not distribute any of the recalled product.