D-1413-2012 Class II Terminated
FDA drug recall D-1413-2012 was initiated by Noven Pharmaceuticals, Inc. on Mar 22, 2012 and is designated Class II. Reason for recall: Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value The recall status is terminated (terminated May 9, 2014). Affected quantity: 185,160 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- Jul 18, 2012
- Initiation Date
- Mar 22, 2012
- Termination Date
- May 9, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 185,160 patches
Product Description
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.
Reason for Recall
Miscalibrated/Defective Delivery System; exceeded the specification for both mechanical peel force (MPF) and/or the z-statistic value
Distribution Pattern
Nationwide and Puerto Rico
Code Information
Lot # 53995
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1413-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026