Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 540
Recalled June 20, 2012 · FDA recall D-1374-2012 · Noven Pharmaceuticals
Hazard
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. · FDA Class II
Units
244,320 patches
Sold at
Nationwide and Puerto Rico.
Description
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.
Product
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.
Manufacturer(s)
Noven Pharmaceuticals, Inc.
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →