Drug product
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/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 68968-5553-3.
D-1655-2012
Product summary
- Event
- Event 62530
- Status
- Terminated
- Classification
- Class II
- Quantity
- 231,270 patches
- Official record key
drug-enforcement:D-1655-2012
Official wording
Reason: Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Code information: Lot #53823, Exp 08/12
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of Specification