Drug product
Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-031-05
D-0636-2020
Product summary
- Event
- Event 84336
- Status
- Terminated
- Classification
- Class I
- Quantity
- N/A
- Official record key
drug-enforcement:D-0636-2020
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
Labeling: Label Error