Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1659-2012·Announced 2012-08-29

Prometheus Recalls Mercaptopurine Tablets for Failed Dissolution Tests

Prometheus Laboratories is recalling specific lots of Mercaptopurine Tablets, 50 mg, because they failed USP dissolution test requirements.

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 explicitly states no illnesses or injuries have been reported, fitting the criteria for a moderate severity score involving low-risk contamination or quality issues without reported harm.

Plain-English summary

Prometheus Laboratories Inc. is recalling specific lots of Mercaptopurine Tablets, USP, 50 mg. The recall involves two package sizes: 60-count bottles (NDC 49884-922-02) and 250-count bottles (NDC 49884-922-04). The product is distributed by Par Pharmaceutical Companies, Inc. The affected lots are 11A003, 11A004, 11A005, 11L071, 11L072, 11B009, and 11L073.

The reason for the recall is that the recalled lots do not meet the specification for dissolution according to USP test requirements. The source text does not report any illnesses or injuries associated with this recall.

The affected products were distributed nationwide and in Puerto Rico. Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the recall notice and contact their pharmacist or the recalling firm for instructions on how to return or dispose of the product.

The recalled product

Product: Mercaptopurine Tablets, USP, 50 mg, packaged in a) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Manufacturer: Prometheus Laboratories Inc.
Category: Drug — Prescription Medication
Hazard: quality-defect

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 (9)

Lot #s: a) 11A003
11A004
11A005
Exp 01/13
11L071
11L072
Exp 10/13
b) 11B009
11L073

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Same manufacturer · Prometheus Laboratories Inc.

See all →

Moderate
Prometheus Recalls Mercaptopurine Tablets for Failed Dissolution Specifications
FDA (Drugs) · 2014-11-26

Same hazard · quality defect