FDAFDA · Food and drugs·Recall number D-1440-2016
Daytrana (methylphenidate transdermal system) Transdermal Patch, 30 mg over 9 hours (3.3 mg/hr), packaged in 30-count patches per box, Rx only, Manufactured by Noven Therapeutics, LLC, Miami, FL 33186; By Noven Pharmaceuticals, Inc., Miami, FL 33186, NDC 68968-5555-3.
Published July 20, 2016 · Recall initiated: December 21, 2015
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
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver 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
- Lot
- Lot #s: 77379, 77380, Exp 05/16; 76944, Exp 03/16
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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