Mercaptopurine Tablets Recalled Due to Failed Dissolution Specifications
Stason Pharmaceuticals recalls Mercaptopurine Tablets, USP 50 mg due to failed dissolution specifications at 9 months. Dissolution results were slightly below the required specification.
The agency’s classification
FDA (Drugs): Class III
Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: This is an FDA Class III recall with no reported illnesses or injuries. The dissolution specification failure is minor (described as 'slightly under spec') with no evidence of patient harm, making it a precautionary recall typical of lower-severity drug recalls.
Plain-English summary
Stason Pharmaceuticals, Inc., which manufactures Mercaptopurine Tablets for Quinn Pharmaceuticals, is recalling the product because certain lots failed to meet dissolution specifications at the 9-month mark. The tablets had dissolution results that were slightly below the required specification, which could affect the medication's performance.
The recall affects Mercaptopurine Tablets, USP 50 mg in two package sizes: 25-count bottles (NDC 69076-913-02) and 250-count bottles (NDC 69076-913-25). A total of 54,131 bottles nationwide are affected. The affected lots with their expiration dates are: 22K012, 22K013A, 22K013B (expires 04/30/2024); 23A001, 23A002A, 23A002B (expires 07/31/2024); 23D006, 23D007A, 23D007B, 23D007C (expires 10/31/2024).
This product is distributed nationwide. Patients taking affected lots should consult their healthcare provider or pharmacist. Do not stop taking the medication without speaking to a healthcare provider, as this is a prescription drug used to treat serious conditions.
The recalled product
- Product
- 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
- Manufacturer
- Stason Pharmaceuticals, Inc.
- Category
- Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (15)
- Lot #: a)22K012
- 22K013A
- Exp: 04/30/2024
- 23A001
- 23A002A
- Exp: 07/31/2024
- 23D006
- 23D007A
- 23D007C
- Exp:10/31/2024
- b)22K013B
- 23A002B
- Exp:07/31/2024
- 23D007B
- Exp: 10/31/2024.
Distribution
Distributed nationwide across the United States.
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