Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , package
Recalled October 1, 2014 · FDA recall D-1608-2014 · Noven Pharmaceuticals
Hazard
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. · FDA Class II
Units
160,800 patches
Sold at
Nationwide.
Description
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.
Product
Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/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 68968-5554-3.
Manufacturer(s)
Noven Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →