FDAFDA · Food and drugs·Recall number D-0429-2017
Daytrana (methylphenidate transdermal system) Transdermal Patch, 20 mg over 9 hours (2.2 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 68968-5554-3.
Published January 18, 2017 · Recall initiated: August 22, 2016
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 and/or the z-statistic values.
What to do
Voluntary: Firm initiated · Letter
Recall details
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Distributor
- Nationwide within the US
- Lot
- Lot #: 79230, Exp. 02/2017; 77547, Exp.07/2016
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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