Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), ...
FDA Recall #D-1439-2016 — Class II — December 21, 2015
Product Description
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
Reason for Recall
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Recalling Firm
Noven Pharmaceuticals, Inc. — Miami, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
2088 boxes
Distribution
Nationwide
Code Information
Lot # 77140, Exp 05/16
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated