Why it was recalled
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Product description
Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
Lot numbers, UPCs & expiration codes
Lot #: a)22K012, 22K013A, Exp: 04/30/2024; 23A001, 23A002A, Exp: 07/31/2024; 23D006, 23D007A, 23D007C, Exp:10/31/2024; b)22K013B, Exp: 04/30/2024; 23A002B, Exp:07/31/2024; 23D007B, Exp: 10/31/2024.
Where it was sold
USA 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-0367-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Feb 9, 2024
- FDA report date
- Mar 13, 2024
- Quantity
- 54, 131 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Stason Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0367-2024, exactly as published.
Show all FDA fields
- City
- Irvine
- State
- CA
- Status
- Terminated
- Country
- United States
- Event ID
- 93960
- Address
- 11 Morgan
- Code information
- Lot #: a)22K012, 22K013A, Exp: 04/30/2024; 23A001, 23A002A, Exp: 07/31/2024; 23D006, 23D007A, 23D007C, Exp:10/31/2024; b)22K013B, Exp: 04/30/2024; 23A002B, Exp:07/31/2024; 23D007B, Exp: 10/31/2024.
- Postal code
- 92618-2005
- Report date
- Mar 13, 2024
- Product type
- Drugs
- Recall number
- D-0367-2024
- Classification
- Class III
- Recalling firm
- Stason Pharmaceuticals, Inc.
- Product quantity
- 54, 131 bottles
- Termination date
- Feb 5, 2026
- Reason for recall
- Failed Dissolution Specifications: results slightly under spec at at 9-months.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
- Distribution pattern
- USA Nationwide
- Recall initiation date
- Feb 9, 2024
- Initial firm notification
- Letter
- Center classification date
- Mar 6, 2024