Drug product
Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours, (1.6 mg/hr), 30 patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5553-3.
D-0071-2023
Product summary
- Event
- Event 91161
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 3977 boxes
- Official record key
drug-enforcement:D-0071-2023
Official wording
Reason: Defective Delivery System: Recalled lot was found to be out of specification for shear. Shear is an attribute related to the adhesive properties of the transdermal patches.
Code information: Lot: 91316 Exp. 02/2023
Distribution pattern: Nationwide in the USA
Derived failure modes
-
Potency or specification failure
out of specification