Drug product
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1.6 mg/hr), Contains: 30 Patches in in a foil-sealed polypropylene tray, packed in a paper carton, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL, 33186, By Noven Pharmaceuticals, Inc., Miami, FL, 33186, NDC 68968-5553-3.
D-0294-2021
Product summary
- Event
- Event 87373
- Status
- Terminated
- Classification
- Class II
- Quantity
- 551,670 patches
- Official record key
drug-enforcement:D-0294-2021
Official wording
Reason: Defective Delivery System: Out of specification for mechanical peel.
Code information: Lots #: 87818, Exp 4/2021, 88274, Exp 5/2021 & 88531, Exp 7/2021.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification