June 2012 FDA Recall Drug by Prometheus Laboratories Inc.
D-1659-2012 - Failed USP Dissolution Test Requirements

This Class II drug recall was voluntarily initiated by Prometheus Laboratories Inc. on June 29, 2012 for the product Drug. The FDA reported the reason for recall as failed usp dissolution test requirements. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1659-2012

Reason for Recall
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Initiated
06-29-2012
Reported
08-29-2012
Quantity
a) 25,516 bottles; b) 2,569 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
62772
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 and Puerto Rico.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
03-27-2013
Product Description About Product Description
Full technical description of the 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.

Batch or Lot Expiration Information

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