May 2012 FDA Recall Drug by Endo Pharmaceuticals, Inc.
D-1381-2012 - Adulterated Presence of Foreign Tablets

This Class III drug recall was voluntarily initiated by Endo Pharmaceuticals, Inc. on May 7, 2012 for the product Drug. The FDA reported the reason for recall as adulterated presence of foreign tablets. The product was distributed Nationwide and the recall is currently terminated.

Recall Number: D-1381-2012

Reason for Recall
Adulterated Presence of Foreign Tablets: Customer complaint that some Endocet 10 mg/325 mg tablets were found mixed in a bottle with Endocet 10 mg/650 mg tablets.
Initiated
05-07-2012
Reported
06-20-2012
Quantity
11,764 bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
61791
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Endo Pharmaceuticals, 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.
06-21-2013
Product Description About Product Description
Full technical description of the product.
Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70.

Batch or Lot Expiration Information

Lot# : 402794NV, Exp 12/13