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 Id 64710

Product Type Drugs

Status Ongoing

Recalling Firm Noven Pharmaceuticals, Inc., Miami, FL, USA


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.