Status
Ongoing
Drug Enforcement D-0367-2024
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Classification
Class III
Report Date
March 13, 2024
Termination Date
—
Product Information
- 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
- Product quantity
- 54, 131 bottles
- Reason for recall
- Failed Dissolution Specifications: results slightly under spec at at 9-months.
- Recall initiation reason
- —
- Initial firm notification
- Letter
- Distribution pattern
- USA Nationwide
Location & Firm
- Recalling firm
- Stason Pharmaceuticals, Inc.
- Address
-
11 Morgan
United States - Voluntary / Mandated
- Voluntary: Firm initiated
- Status date
- —
Codes & Dates
- Recall number
- D-0367-2024
- Event ID
- 93960
- Recall initiation date
- February 9, 2024
- Center classification date
- March 6, 2024
- Code info
- 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.
- More code info
- —