Class II
Terminated
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/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 68968-5553-3.
This recall has been terminated (originally issued August 29, 2012).
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- July 12, 2012
- Posted
- August 29, 2012
- Recall Number
- D-1655-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 231,270 patches
- Firm Location
- Miami, FL, United States
- Official Source
- View on FDA website ↗
Reason for Recall
Miscalibrated and/or Defective Delivery System: Out of Specification results for mechanical peel force and/or the z-statistic value which relates to the patient's ability to remove the release liner from the patch adhesive prior to administration.
Distribution
Nationwide and Puerto Rico.
Lot / Code Info
Lot #53823, Exp 08/12
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