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U.S. Department of Health and Human Services

Enforcement Report - Week of May 8, 2013

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Product Detail

Product Description Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5552-3.
Recall Number D-312-2013
Classification Class II
Code Info Lot #59824, Exp 04/13
Product Distributed Qty 335,910 patches
Reason For Recall Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.

Event Detail

Event Id 64710
Product Type Drugs
Status Ongoing
Recalling Firm Noven Pharmaceuticals, Inc.
City Miami
State FL
Country US
Voluntary / Mandated Voluntary: Firm Initiated
Recall Initiation Date 2013-01-31
Initial Firm Notification of Consignee or Public Letter
Distribution Pattern Nationwide and Puerto Rico.