FDAFDA · Food and drugs·Recall number D-0636-2020
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
Published December 18, 2019 · Recall initiated: November 20, 2019
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MIRTAZAPINE
- Manufacturer
- AuroMedics Pharma LLC
- Distributor
- Nationwide
- Lot
- Lot #: 03119002A3, Exp 3/2022
- Risk classification
- Class I
- Area (FDA)
- drug
- Country
- United States
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