Where it's made
| Factory | Where | Role | Last FDA inspection |
|---|---|---|---|
| Stason Pharmaceuticals, Inc. | Irvine, California, United States | Makes it | Problems found, fixed voluntarilyApr 13, 2021 · 11 inspections, 1 with FDA action |
Recalls
- Feb 9, 2024 · Class III · Stason Pharmaceuticals, Inc.
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Lots: 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.
Class I recalls are the most serious; Class III the least. A recall covers specific lots, listed on each recall.
Product details
- Generic drug
- Mercaptopurine: every company that makes it
- Form
- tablet
- Strength
- 50 mg
- Approval
- NDA authorized generic NDA009053
- On the market since
- Oct 5, 2016
- Package NDCs
69076-913-0269076-913-25- Official label
- DailyMed (National Library of Medicine), updated Jul 23, 2024
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