Aurobindo Pharma USA, Inc. is voluntarily recalling one lot of Mirtazapine tablets to the consumer level. 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.
Recalled Product
- Packaging: 500 count bottles (7.5mg and 15mg)
- Lot number: 03119002A3
- Expiration date: 03/2022
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.
Any general questions regarding the return of this product please contact Qualanex at 1-888-504-2014 or email mecall@qualanex.com(live calls received 7:00 am to 4:00 pm M-F CST).
—Source: FDA
