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Aurobindo Pharma USA, Inc. Recalls Mirtazapine 7.5 mg tablet

Date: 01/15/20

Attention Members and Providers: MHS wants you to know about a recent drug recall.

On January 2, 2020, the U.S. Food and Drug Administration (FDA) announced that Aurobindo Pharma USA, Inc. was recalling Mirtazapine 7.5 mg tablet, lot #03119002A3 to the consumer level due to a label error on declared strength; bottles labeled as Mirtazapine 7.5 mg may contain 15 mg tablets.

  • The FDA press release states the following: Aurobindo Pharma USA, Inc. is voluntarily recalling lot number 03119002A3 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.
  • Taking a higher dose than expected, 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/retailers that have product which is being recalled should return the bottle(s) to place of purchase.

Providers can review the FDA’s full press release here.