D-1372-2012 Class II Terminated
FDA drug recall D-1372-2012 was initiated by Noven Pharmaceuticals, Inc. on Jul 5, 2011 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 May 23, 2013). Affected quantity: 357,510 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- Jun 20, 2012
- Initiation Date
- Jul 5, 2011
- Termination Date
- May 23, 2013
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 357,510 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, labeled as a) Manufactured for Shire US Inc., Wayne, PA 19087 by Noven Pharmaceuticals, Inc., Miami, FL 33186; NDC 54092-554-30; b) 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 #'s: a) 49203, Exp 10/12; b) 50265, Exp 01/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1372-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026