Drug product
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch 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 68968-5554-3.
D-1171-2014
Product summary
- Event
- Event 67718
- Status
- Terminated
- Classification
- Class II
- Quantity
- 187,860 patches
- Official record key
drug-enforcement:D-1171-2014
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 #69618, Exp. 09/14
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Out of Specification