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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 Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
Recall Number D-1372-2012
Classification Class II
Code Info Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13
Product Distributed Qty 357,510 patches
Reason For Recall Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.

Event Detail

Event Id 61891
Product Type Drugs
Status Ongoing
Recalling Firm Noven Pharmaceuticals, Inc.
City Miami
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2011-07-05
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico.