Class II
Terminated
Daytrana (methylphenidate) transdermal system patch, Delivers 30 mg over 9 hours (3.3 mg/hr), 1 patch per pouch (NDC 54092-555-01), packaged in 30-count patches per box (NDC 54092-555-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186.
This recall has been terminated (originally issued June 20, 2012).
- Company
- Noven Pharmaceuticals, Inc.
- Recall Initiated
- July 5, 2011
- Posted
- June 20, 2012
- Recall Number
- D-1373-2012
- Voluntary / Mandated
- Voluntary: Firm initiated
- Quantity
- 242,100 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 #: 43008, Exp 01/12; 48591, Exp 10/12
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