FDAFDA · Food and drugs·Recall number D-1235-2020
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Published April 22, 2020 · Recall initiated: March 18, 2020
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
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- MIRTAZAPINE
- Manufacturer
- Aurobindo Pharma USA Inc.
- Distributor
- Nationwide within the United States
- Lot
- Lot #: 031180028A, Exp. Date 03/2021
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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