December 20, 2019
AuroMedics Pharma is recalling a single lot of mirtazapine tablets over a label error concerning the tablet strength, according to the December 18, 2019, US Food and Drug Administration (FDA) Enforcement Report.
“The batch number used in the 7.5-mg label corresponds to the 15-mg mirtazapine tablets,” the FDA reported. “Therefore, mirtazapine 15-mg cases may include bottles mislabeled as 7.5 mg but full of 15-mg tablets.”
The recall affects mirtazapine tablets, 7.5 mg, 500-count bottles (NDC 13107-001-05) from lot 03119002A3 (Exp. 3/22). The tablets were distributed by Aurobindo Pharma USA throughout the United States.
AuroMedics Pharma voluntarily initiated the recall November 20, 2019. The FDA had not yet issued a recall classification at press time.
Mirtazapine is a prescription antidepressant.