Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 p...
FDA Recall #D-1374-2012 — Class II — July 5, 2011
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186.
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.
Recalling Firm
Noven Pharmaceuticals, Inc. — Miami, FL
Classification
Class II — May cause temporary or medically reversible adverse health consequences.
Product Type
Drugs
Product Quantity
244,320 patches
Distribution
Nationwide and Puerto Rico.
Code Information
Lot #: 43783, Exp 01/12
Status
Terminated
Voluntary / Mandated
Voluntary: Firm initiated