Drug product
Daytrana (methylphenidate transdermal system) Transdermal Patch, 10 mg over 9 hours (1.1mg/hr), packaged in- 30 count per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc, Miami, FL 33186, NDC 68968-5552-3
D-0428-2017
Product summary
- Event
- Event 75450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 1,068,600 patches
- Official record key
drug-enforcement:D-0428-2017
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 #: 77545, Exp.07/2016; 78035, Exp. 08/2016; 78367, Exp. 10/2016; 79919, Exp. 03/2017.
Distribution pattern: Nationwide within the US
Derived failure modes
-
Potency or specification failure
Out of Specification