Drug recall D-0636-2020
Product
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
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.
Lots and codes
Lot #: 03119002A3, Exp 3/2022
Recall details
- Recalling firm
- AuroMedics Pharma LLC, East Windsor, NJ
- Quantity
- N/A
- Distribution
- Nationwide
- Type
- Voluntary: Firm initiated
- Recall initiated
- November 20, 2019
- Terminated
- February 21, 2024
Related products
- Mirtazapine – drug information
- NDC 13107-001 Mirtazapine · Mirtazapine 7.5 mg/1 · Aurolife Pharma LLC
- NDC 13107-032 Mirtazapine · Mirtazapine 45 mg/1 · Aurolife Pharma LLC
- NDC 13107-003 Mirtazapine · Mirtazapine 30 mg/1 · Aurolife Pharma LLC
- NDC 13107-031 Mirtazapine · Mirtazapine 15 mg/1 · Aurolife Pharma LLC