Class II
Terminated
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2mg/hr), 1 patch per pouch , packaged in 30-count patches per box, Rx Only. Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186. NDC 68968-5554-3.
This recall has been terminated (originally issued March 26, 2014).
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- February 13, 2014
- Posted
- March 26, 2014
- Recall Number
- D-1171-2014
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 187,860 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 z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Distribution
Nationwide.
Lot / Code Info
Lot #69618, Exp. 09/14
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