Recalls / Class II
Class IID-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
- Brand name
- Mirtazapine
- Generic name
- Mirtazapine
- Active ingredient
- Mirtazapine
- Route
- Oral
- NDCs
- 13107-001, 13107-031, 13107-003, 13107-032
- FDA application
- ANDA076921
- Affected lot / code info
- Lot #: 031180028A, Exp. Date 03/2021
Why it was recalled
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Recalling firm
- Firm
- Aurobindo Pharma USA Inc.
- Manufacturer
- Aurolife Pharma LLC
- Notification channel
- Letter
- Type
- Voluntary: Firm initiated
- Address
- 279 Princeton Hightstown Rd, East Windsor, New Jersey 08520-1401
Distribution
- Quantity
- 56208 units
- Distribution pattern
- Nationwide within the United States
Timeline
- Recall initiated
- 2020-03-18
- FDA classified
- 2020-04-13
- Posted by FDA
- 2020-04-22
- Terminated
- 2024-03-25
- Status
- Terminated
Source: openFDA Drug Enforcement endpoint. Recall record D-1235-2020. The FDA issues recall classifications as health-hazard assessments, not legal findings; for legal claims consult a licensed attorney.