October 2014 FDA Recall Drug by Prometheus Laboratories Inc.
D-0249-2015 - Failed Dissolution Specifications

This Class II drug recall was voluntarily initiated by Prometheus Laboratories Inc. on October 22, 2014 for the product Drug. The FDA reported the reason for recall as failed dissolution specifications. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-0249-2015

Reason for Recall
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Initiated
10-22-2014
Reported
11-26-2014
Quantity
16,296 bottles (60-count), 5,166 bottles (250-count)

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
69572
Classification About Classification
Relative degree of health hazard assigned by FDA.
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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Prometheus Laboratories Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Nationwide
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-18-2016
Product Description About Product Description
Full technical description of the 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

Batch or Lot Expiration Information

Lot# 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
Lot# : a) 140B11, Exp Feb 2016; 14B012, Exp Feb 2016; 14B013, Exp Feb 2016
Lot# : b) 13F046, Exp Jun 2015; 13K073, Exp Oct 2015; 13L075, Exp Oct 2015; 14B010, Exp Feb 2016.