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U.S. Department of Health and Human Services

Enforcement Report - Week of June 20, 2012

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Product Detail

Product Description 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.
Recall Number D-1381-2012
Classification Class III
Code Info Lot #: 402794NV, Exp 12/13
Product Distributed Qty 11,764 bottles
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.

Event Detail

Event Id 61791
Product Type Drugs
Status Ongoing
Recalling Firm Endo Pharmaceuticals, Inc.
City Chadds Ford
State PA
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2012-05-07
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico