Why it was recalled
CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
Product description
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
Lot numbers, UPCs & expiration codes
Lot #: 031180028A, Exp. Date 03/2021
Where it was sold
Nationwide within the United States
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-1235-2020
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- Mar 18, 2020
- FDA report date
- Apr 22, 2020
- Quantity
- 56208 units
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Aurobindo Pharma USA Inc.
Original FDA data
Every field from FDA enforcement report D-1235-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 85183
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: 031180028A, Exp. Date 03/2021
- Postal code
- 08520-1401
- Report date
- Apr 22, 2020
- Product type
- Drugs
- Recall number
- D-1235-2020
- Classification
- Class II
- Recalling firm
- Aurobindo Pharma USA Inc.
- Product quantity
- 56208 units
- Termination date
- Mar 25, 2024
- Reason for recall
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
- Distribution pattern
- Nationwide within the United States
- Recall initiation date
- Mar 18, 2020
- Initial firm notification
- Letter
- Center classification date
- Apr 13, 2020