Drug product
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
D-1248-2020
Product summary
- Event
- Event 85357
- Status
- Terminated
- Classification
- Class II
- Quantity
- 5,614 30-count boxes
- Official record key
drug-enforcement:D-1248-2020
Official wording
Reason: Defective Delivery System: Out of specification for mechanical peel and shear.
Code information: Lot: 86354 Exp. 08/2020
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Potency or specification failure
Out of specification