Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma U...
FDA Recall #D-0637-2020 — Class I — November 20, 2019
Product Description
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
Reason for Recall
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Recalling Firm
AuroMedics Pharma LLC — East Windsor, NJ
Classification
Class I — Reasonable probability of serious adverse health consequences or death.
Product Type
Drugs
Product Quantity
N/A
Distribution
Nationwide
Code Information
Lot #: 03119002A3, Exp 3/2022
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated