Drug recall D-1235-2020
Product
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Reason for recall
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Lots and codes
Lot #: 031180028A, Exp. Date 03/2021
Recall details
- Recalling firm
- Aurobindo Pharma USA Inc., East Windsor, NJ
- Quantity
- 56208 units
- Distribution
- Nationwide within the United States
- Type
- Voluntary: Firm initiated
- Recall initiated
- March 18, 2020
- Terminated
- March 25, 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