Drug product
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3
D-1249-2020
Product summary
- Event
- Event 85357
- Status
- Terminated
- Classification
- Class II
- Quantity
- 14,142 30-count boxes
- Official record key
drug-enforcement:D-1249-2020
Official wording
Reason: Defective Delivery System: Out of specification for mechanical peel and shear.
Code information: Lots: 86355 Exp. 07/2020; 86356 Exp.08/2020; 86550 Exp. 07/2020; 87348 Exp. 01/2021; 87965 Exp. 01/2021
Distribution pattern: Distributed Nationwide in the US
Derived failure modes
-
Potency or specification failure
Out of specification