Drug product
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) Contains: 30 Patches 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 68968-5555-3.
D-0296-2021
Product summary
- Event
- Event 87373
- Status
- Terminated
- Classification
- Class II
- Quantity
- 934,140 patches
- Official record key
drug-enforcement:D-0296-2021
Official wording
Reason: Defective Delivery System: Out of specification for mechanical peel.
Code information: Lots #: 87377, Exp 3/2021, 87572, Exp 3/2021, 87581, Exp 4/2021, 87820, Exp 5/2021, 88246, Exp 6/2021, 88535, Exp 7/2021, 88536, Exp 8/2021, 88537, Exp 8/2021 & 88939, Exp 8/2021.
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
Out of specification