Mirtazapine tablets recalled due to labeling error

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 [email protected](live calls received 7:00 am to 4:00 pm M-F CST).

—Source: FDA

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