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

February 13, 2014

Class II

Product summary

Firm: Noven Pharmaceuticals, Inc.
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
reason.potency_specification_failure · v1.0.0

Out of Specification