Drug product
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
D-1235-2020
Product summary
- Event
- Event 85183
- Status
- Terminated
- Classification
- Class II
- Quantity
- 56208 units
- Official record key
drug-enforcement:D-1235-2020
Official wording
Reason: CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Code information: Lot #: 031180028A, Exp. Date 03/2021
Distribution pattern: Nationwide within the United States
Derived failure modes
-
Manufacturing or process control
CGMP Deviations