FDAFDA · Food and drugs·Recall number D-1372-2012
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
Published June 20, 2012 · Recall initiated: July 5, 2011
Status when published: Terminated — openFDA updates weekly, so this field may not reflect the current status. Always confirm with the official notice.
What's the hazard
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.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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