Prometheus Recalls Mercaptopurine Tablets for Failed Dissolution Specifications
Prometheus Laboratories is recalling Mercaptopurine Tablets 50mg because the product failed dissolution specifications during stability testing.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving potential harm without confirmed adverse events.
Plain-English summary
Prometheus Laboratories, Inc. is recalling Mercaptopurine Tablets, USP 50mg, in 60-count and 250-count bottles. The recall involves specific lots manufactured by Stason Pharmaceuticals, Inc. for Prometheus Laboratories, Inc.
The recall was initiated because the product was found to be out of specification (OOS) during stability testing, specifically regarding failed dissolution specifications. This means the tablets may not dissolve at the required rate, which could affect the delivery of the medication.
The affected products are prescription-only (RX only) and were distributed nationwide. Consumers and healthcare providers should check their inventory for the specific NDCs and lot numbers listed in the recall notice. If the product is found, it should be returned to the pharmacy or supplier for replacement or refund.
The recalled product
- Product
- Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121
- Manufacturer
- Prometheus Laboratories Inc.
- Category
- Drug — Prescription Medication
- 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 (20)
- Mercaptopurine Tablets
- USP 50mg
- a) 60-count bottle (NDC 49884-922-02)
- b) 250-count bottle (NDC 49884-922-04)
- RX only
- Manufactured by Stason Pharmaceuticals
- Inc.
- 11 Morgan
- Irvine
- CA 92618 for Prometheus Laboratories
- 9410 Carroll Park Drive
- San Diego
- CA 92121 Lot #: a) 140B11
- Exp Feb 2016
- 14B012
- 14B013
- Exp Feb 2016 Lot #: b) 13F046
- Exp Jun 2015
- 13K073
- Exp Oct 2015
Distribution
Distributed nationwide across the United States.
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