| Recall Number | D-1372-2012 |
|---|---|
| Recalling Firm | Noven Pharmaceuticals, Inc. |
| Classification | Class II |
| Voluntary / Mandated | Voluntary: Firm initiated |
| Distribution Pattern | Nationwide and Puerto Rico. |
| Status | Terminated |
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
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.
Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13