D-1653-2012 Class II Terminated
FDA drug recall D-1653-2012 was initiated by Noven Pharmaceuticals, Inc. on Jul 12, 2012 and is designated Class II. Reason for recall: 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… The recall status is terminated (terminated Aug 4, 2014). Affected quantity: 177,900 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- Aug 29, 2012
- Initiation Date
- Jul 12, 2012
- Termination Date
- Aug 4, 2014
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 177,900 patches
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 20 mg over 9 hours (2.2 mg/hr), 1 patch per pouch, packaged in 30-count patches per box, Rx only, Manufactured for Noven Therapeutics, LLC, Miami, FL 33186, By Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 68968-5554-3.
Reason for Recall
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.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot # 55302, Exp 12/12
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1653-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026