Mirtazapine Tablets recall: CGMP Deviations
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Why was Mirtazapine Tablets recalled?
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
What should I do if I have this product?
Review the official FDA enforcement record for current instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot #: 031180028A, Exp. Date 03/2021
- Product
- Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
- Recalling firm
- Aurobindo Pharma USA Inc.
- Quantity
- 56208 units
- Distribution
- Nationwide within the United States
- Recall date
- April 22, 2020
- Classification
- Class II
- Status
- Terminated
- Agency
- FDA (drug)