RecallDepth
Class II Terminated

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.

This recall has been terminated (originally issued July 18, 2012).

Company
Noven Pharmaceuticals, Inc.
Recall Initiated
March 22, 2012
Posted
July 18, 2012
Recall Number
D-1413-2012
Voluntary / Mandated
Voluntary: Firm initiated
Quantity
185,160 patches
Firm Location
Miami, FL, United States
Official Source
View on FDA website ↗

Reason for Recall

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

Distribution

Nationwide and Puerto Rico

Lot / Code Info

Lot # 53995

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