drugs Class II Updated 2013-05-08

Noven Pharmaceuticals, Inc. recalls Daytrana (methylphenidate) transdermal system patch, Deliver

Recalled Product

Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/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 68968-5552-3.

Hazard / Issue

Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot #59824, Exp 04/13
View official government recall

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