Drug product
Daytrana (methylphenidate transdermal system), 30 mg over 9 Hour Patches (3.3 mg/hr), 30 Ct Carton, Rx Only, Manufactured for: Noven Therapies, LLC., Miami, FL 33186, by: Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC: 68968-5555-3
D-0008-2016
Product summary
- Event
- Event 72174
- Status
- Terminated
- Classification
- Class II
- Quantity
- 125,250 Patches
- Official record key
drug-enforcement:D-0008-2016
Official wording
Reason: Defective Delivery System: Out of specification for z-statistic related to mechanical peel force.
Code information: Lot #: 75983, Expiry: 11/15
Distribution pattern: US Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification