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Recall Observatory FDA recall evidence

Drug product

Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05

D-0637-2020

November 20, 2019

Class I

Product summary

Firm
AuroMedics Pharma LLC
Event
Event 84336
Status
Terminated
Classification
Class I
Quantity
N/A
Official record key
drug-enforcement:D-0637-2020

Official wording

Reason: 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.

Code information: Lot #: 03119002A3, Exp 3/2022

Distribution pattern: Nationwide

Derived failure modes

  • Labeling or packaging

    reason.labeling_packaging · v1.0.0

    Labeling: Label Error