FDA Recall D-0636-2020
AuroMedics Pharma LLC · East Windsor, NJ
Class I — life-threatening Terminated 1554 days on record
Highest impact — Class I recall — FDA determination of strong likelihood of serious adverse health consequence or death.
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.
Recall record
- Recall number
D-0636-2020- Classification
- Class I
- Status
- Terminated
- Voluntary or mandated
- Voluntary: Firm initiated
- Firm notification
- Letter
- Distribution
- Nationwide
- Recall initiated
- 2019-11-20
- Classified by FDA Center
- 2020-01-02
- FDA published
- 2019-12-18
- Terminated
- 2024-02-21
- Recalling firm
- AuroMedics Pharma LLC
- Firm location
- East Windsor, NJ
Drug identification
- Brand name(s)
- MIRTAZAPINE
- Generic name(s)
- MIRTAZAPINE
- Manufacturer(s)
- Aurolife Pharma LLC
- NDC(s)
13107-001, 13107-031, 13107-003, 13107-032- Route(s)
- ORAL