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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 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186.
Recall Number D-1373-2012
Classification Class II
Code Info Lot #: 43008, Exp 01/12; 48591, Exp 10/12
Product Distributed Qty 242,100 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.
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