FDA Media Alert Detail

Drug Recall

FDA Drug Recall: Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx o...

  • U.S. Food and Drug Administration
  • June 20, 2012
  • ID: D-1381-2012

Drug Enforcement Report Details

Recall NumberD-1381-2012
Recalling FirmEndo Pharmaceuticals, Inc.
ClassificationClass III
Voluntary / MandatedVoluntary: Firm initiated
Distribution PatternNationwide and Puerto Rico
StatusTerminated
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.

Code Information

Lot #: 402794NV, Exp 12/13


Content syndicated from the U.S. Food and Drug Administration (FDA) drug enforcement reports database.