Why it was recalled
Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
Product description
Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
Lot numbers, UPCs & expiration codes
Lot #: 03119002A3, Exp 3/2022
Where it was sold
Nationwide
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-0637-2020
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- Nov 20, 2019
- FDA report date
- Dec 18, 2019
- Quantity
- N/A
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- AuroMedics Pharma LLC
Original FDA data
Every field from FDA enforcement report D-0637-2020, exactly as published.
Show all FDA fields
- City
- East Windsor
- State
- NJ
- Status
- Terminated
- Country
- United States
- Event ID
- 84336
- Address
- 279 Princeton Hightstown Rd
- Code information
- Lot #: 03119002A3, Exp 3/2022
- Postal code
- 08520-1401
- Report date
- Dec 18, 2019
- Product type
- Drugs
- Recall number
- D-0637-2020
- Classification
- Class I
- Recalling firm
- AuroMedics Pharma LLC
- Termination date
- Feb 21, 2024
- Reason for recall
- Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bottles, contain 500-count bottles of Mirtazapine 15mg tablets labelled as Mirtazapine 7.5 mg tablets.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810 NDC 13107-001-05
- Distribution pattern
- Nationwide
- Recall initiation date
- Nov 20, 2019
- Initial firm notification
- Letter
- Center classification date
- Jan 2, 2020