Drug product
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
D-0429-2017
Product summary
- Event
- Event 75450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 364,830 patches
- Official record key
drug-enforcement:D-0429-2017
Official wording
Reason: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and and/or the z-statistic values.
Code information: Lot #: 79230, Exp. 02/2017; 77547, Exp.07/2016
Distribution pattern: Nationwide within the US
Derived failure modes
-
Potency or specification failure
Out of Specification