drugs Class II Updated 2012-08-29

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

Recalled Product

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, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.

Hazard / Issue

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.

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 55302, Exp 12/12
View official government recall

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