Drug product
Daytrana (methylphenidate transdermal system) CII, 30 mg, 30-count carton, Rx only, Manufactured for Noven Therapeutics, LLC., Miami by Noven Pharmaceuticals, Inc., NDC 68968-5555-3
D-0473-2023
Product summary
- Event
- Event 91882
- Status
- Ongoing
- Classification
- Class II
- Quantity
- N/A
- Official record key
drug-enforcement:D-0473-2023
Official wording
Reason: Defective Delivery System: Out of specification for shear.
Code information: Lot#: 91474, 91959, Exp. 3/2023; 91958, Exp. 6/2023; 92478, Exp. 7/2023; 92479 & 92198, Exp. 8/2023; 92199, 93040, Exp. 9/2023; 93041, Exp. 10/2023.
Distribution pattern: US Nationwide
Derived failure modes
-
Potency or specification failure
Out of specification