D-1375-2012 Class II Terminated
FDA drug recall D-1375-2012 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: 335,190 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
- 335,190 patches
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc., Miami, FL 33186.
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 #: 41843, Exp 11/11
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1375-2012
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026