FDAFDA · Food and drugs·Recall number D-1374-2012
Daytrana (methylphenidate) transdermal system patch, Delivers 15 mg over 9 hours (1.6 mg/hr), 1 patch per pouch (NDC 54092-553-01), packaged in 30-count patches per box (NDC 54092-553-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186.
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
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Distributor
- Nationwide and Puerto Rico.
- Lot
- Lot #: 43783, Exp 01/12
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States