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Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.
Aurobindo Pharma USA, Inc. announced on Dec. 30, 2019 that it was voluntarily recalling on lot of Mirtazapine tablets because the label on the bottles incorrectly stated the strength as Mirtazapine 7.5 mg, but the product may contain 15 mg tablets. Mirtazapine tablets are used to treat major depressive disorder. The company stated in a press release that taking a higher dose may increase risks such as sedation, agitation, increased reflexes, tremor, and gastrointestinal distress, among other symptoms.
The recalled lot, 03119002A3, has an expiration date of 03/2022 and is packaged in 500-count bottles. Adverse events may be reported to FDA through its MedWatch program.