D-1608-2014 Class II Terminated
FDA drug recall D-1608-2014 was initiated by Noven Pharmaceuticals, Inc. on Jul 15, 2014 and is designated Class II. Reason for recall: Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner… The recall status is terminated (terminated Mar 19, 2019). Affected quantity: 160,800 patches.
Recall Details
- Product Type
- Drugs
- Report Date
- Oct 1, 2014
- Initiation Date
- Jul 15, 2014
- Termination Date
- Mar 19, 2019
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 160,800 patches
Product Description
Daytrana (methylphenidate transdermal system) patch, Delivers 20 mg over 9 hours (2.2mg/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
Defective Delivery System: Out of Specification (OOS) results for the mechanical peel force (MPF) and z-statistic value which relates to the patients and caregiver ability to remove the release liner from the patch adhesive prior to administration.
Distribution Pattern
Nationwide.
Code Information
Lot # 71165; Exp. 12/14
Source
- Dataset
- openFDA drug recall enforcement reports
- FDA record
- This recall in openFDA (JSON)
- Enforcement Report
- Search FDA's Enforcement Report for D-1608-2014
- openFDA file date
- Oct 26, 2026
- Loaded by RegDataLab
- Oct 27, 2026