Drug product
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches Rx Only NDC 68968-5552-3 Manufactured for Noven Therapeutics, LLC., Miami, FL 33186 by Noven Pharmaceuticals, Inc. Miami, FL 33186 1-877-567-7857
D-0627-2018
Product summary
- Event
- Event 79781
- Status
- Terminated
- Classification
- Class II
- Quantity
- 9016 boxes of 30 patch each
- Official record key
drug-enforcement:D-0627-2018
Official wording
Reason: Defective Delivery System: Out of specification for adhesive transfer.
Code information: Lot #: 82237 Exp. May 31, 2018
Distribution pattern: Nationwide.
Derived failure modes
-
Potency or specification failure
Out of specification