Drug product
Daytrana (methylphenidate transdermal system), Delivers 30 mg over 9 hours (3.3mg/hr), CII, 30 patches per box, Manufactured for Noven Therapeutics LLC, Miami, FL 33186, by Noven Pharmaceuticals Inc., Miami, FL 33186, NDC # 68968-5555-3
D-1086-2015
Product summary
- Event
- Event 71201
- Status
- Terminated
- Classification
- Class II
- Quantity
- 125,340 Patches
- Official record key
drug-enforcement:D-1086-2015
Official wording
Reason: Defective Delivery System: One lot exceeded the mechanical peel specification
Code information: Lot # 73346, Exp 03/2015
Distribution pattern: Nationwide
Derived failure modes
-
Unknown
Defective Delivery System: One lot exceeded the mechanical peel specification