Drug product
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
D-1372-2012
Product summary
- Event
- Event 61891
- Status
- Terminated
- Classification
- Class II
- Quantity
- 357,510 patches
- Official record key
drug-enforcement:D-1372-2012
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 #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13
Distribution pattern: Nationwide and Puerto Rico.
Derived failure modes
-
Potency or specification failure
Out of Specification