Drug 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.
D-1413-2012
Product summary
- Event
- Event 62002
- Status
- Terminated
- Classification
- Class II
- Quantity
- 185,160 patches
- Official record key
drug-enforcement:D-1413-2012
Official wording
Reason: Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Code information: Lot # 53995
Distribution pattern: Nationwide and Puerto Rico
Derived failure modes
-
Unknown
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value