FDAFDA · Food and drugs·Recall number D-1413-2012
Daytrana (Methylphenidate) Transdermal System Patch, Delivers 20 mg over 9 hours (2. 2 mg/hr), 1 patch per pouch (NDC 68968-5554-01) packaged in 3-count patches per box (NDC 68968-5554-3) , Rx only, Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33816.08/04/12.
Published July 18, 2012 · Recall initiated: March 22, 2012
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/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
What to do
Voluntary: Firm initiated · Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
Recall details
- Brand
- DAYTRANA
- Manufacturer
- Noven Pharmaceuticals, Inc.
- Distributor
- Nationwide and Puerto Rico
- Lot
- Lot # 53995
- Risk classification
- Class II
- Area (FDA)
- drug
- Country
- United States
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