Drug product
Daytrana (methylphenidate transdermal system) patches, Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC. Miami, FL 33186, NDC 68968-5552-3
D-1042-2020
Product summary
- Event
- Event 85128
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9513 boxes
- Official record key
drug-enforcement:D-1042-2020
Official wording
Reason: Defective Delivery System: Out of specification for mechanical peel and shear.
Code information: Lot#: 86280, Exp 06/2020
Distribution pattern: U.S.A. Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification