Class II
Terminated
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 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 68968-5555-3.
This recall has been terminated (originally issued January 18, 2017).
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- August 22, 2016
- Posted
- January 18, 2017
- Recall Number
- D-0430-2017
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 357,420 patches
- 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 and/or the z-statistic values.
Distribution
Nationwide within the US
Lot / Code Info
Lot #: 77306, Exp.05/2016; 77595 Exp. 07/2016; 78069, Exp.08/2016.
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