Drug product
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr) Contains: 30 Patches, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5552-3
D-0889-2022
Product summary
- Event
- Event 90162
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 274, 110 patches
- Official record key
drug-enforcement:D-0889-2022
Official wording
Reason: Defective Delivery System: customer complaints exceeded respective action limits.
Code information: Lot: 90764 Exp. 08/2022
Distribution pattern: Nationwide to the U.S. Market
Derived failure modes
-
Unknown
Defective Delivery System: customer complaints exceeded respective action limits.