Drug product
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 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 68968-5555-3.
D-0430-2017
Product summary
- Event
- Event 75450
- Status
- Terminated
- Classification
- Class II
- Quantity
- 357,420 patches
- Official record key
drug-enforcement:D-0430-2017
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 #: 77306, Exp.05/2016; 77595 Exp. 07/2016; 78069, Exp.08/2016.
Distribution pattern: Nationwide within the US
Derived failure modes
-
Potency or specification failure
Out of Specification