drugs Class II Updated 2012-07-18

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 (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.

Hazard / Issue

Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot # 53995
View official government recall

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