Class II
Terminated
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5554-3.
This recall has been terminated (originally issued July 20, 2016).
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- December 21, 2015
- Posted
- July 20, 2016
- Recall Number
- D-1439-2016
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 2088 boxes
- Firm Location
- Miami, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Distribution
Nationwide
Lot / Code Info
Lot # 77140, Exp 05/16
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