Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3

Recall Number: D-0008-2016

Firm: Noven Pharmaceuticals, Inc.

Classification: Class II

Status: Terminated

Report Date: 20151014

Initiation Date: 20150727

Termination Date: 20190320

Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.

Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3