Drug product
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Rx Only Contains: 30 Patches Manufactured for: Noven Therapeutics, LLC. Miami, FL 33186 By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC# 68968-5555-3
D-1171-2017
Product summary
- Event
- Event 78021
- Status
- Terminated
- Classification
- Class II
- Quantity
- 331,950 patches
- Official record key
drug-enforcement:D-1171-2017
Official wording
Reason: Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.
Code information: Lot: 80442 Exp. 10/17 Lot: 80439 Exp. 08/17 Lot: 80438 Exp. 08/17
Distribution pattern: Nationwide.
Derived failure modes
-
Unknown
Defective Delivery System: Products no longer meet the release liner removal specification and/or z-statistic.