D-312-2013 Class II Terminated
FDA drug recall D-312-2013 was initiated by Noven Pharmaceuticals, Inc. on Jan 31, 2013 and is designated Class II. Reason for recall: Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior… The recall status is terminated (terminated Dec 28, 2016). Affected quantity: 335,910 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- May 8, 2013
- Initiation Date
- Jan 31, 2013
- Termination Date
- Dec 28, 2016
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 335,910 patches
Product Description
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 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 68968-5552-3.
Reason for Recall
Defective Delivery System: Out of Specification (OOS) results for the z-statistic value, which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration, were obtained.
Distribution Pattern
Nationwide and Puerto Rico.
Code Information
Lot #59824, Exp 04/13
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-312-2013
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026