Drug product
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3mg/hr), 1patch per pouch , packaged in 30-count patches per box, Rx Only.Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5555-3.
D-1172-2014
Product summary
- Event
- Event 67718
- Status
- Terminated
- Classification
- Class II
- Quantity
- 117,600 patches
- Official record key
drug-enforcement:D-1172-2014
Official wording
Reason: Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Code information: Lot #70132, Exp. 09/14
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Out of Specification