Drug product
Daytrana (methylphenidate transdermal system) Transdermal Patch, 15 mg over 9 hours (1.6 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 68968-5553-3.
D-1438-2016
Product summary
- Event
- Event 73718
- Status
- Terminated
- Classification
- Class II
- Quantity
- 7850 boxes
- Official record key
drug-enforcement:D-1438-2016
Official wording
Reason: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Code information: Lot #: 77303, Exp 06/16
Distribution pattern: Nationwide
Derived failure modes
-
Potency or specification failure
Out of Specification