D-1381-2012 Class III Terminated

Recalled by Endo Pharmaceuticals, Inc. — Chadds Ford, PA

Recall Details

Product Type
Drugs
Report Date
June 20, 2012
Initiation Date
May 7, 2012
Termination Date
June 21, 2013
Voluntary/Mandated
Voluntary: Firm initiated
Product Quantity
11,764 bottles

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.

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.

Distribution Pattern

Nationwide and Puerto Rico

Code Information

Lot #: 402794NV, Exp 12/13